Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- # Substance Stability Study a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundle-drug-stability-pq-ex2-sub"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq> ] ) ] ; # fhir:type [ fhir:v "collection"] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "urn:uuid:54c8e8dc-9a19-0dc2-910e-d5a05d6ba003"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:54c8e8dc-9a19-0dc2-910e-d5a05d6ba003> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:c3973835-10ca-0796-0a26-aa8afafc9c5b"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:c3973835-10ca-0796-0a26-aa8afafc9c5b> ) # Section 11 - Stability Study - Protocol ] [ fhir:fullUrl [ fhir:v "urn:uuid:643d8b44-71f4-2b58-07e8-51c22b294b25"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:643d8b44-71f4-2b58-07e8-51c22b294b25> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:10d7b693-7a0e-2f71-9a10-642e5a0a5d42"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:10d7b693-7a0e-2f71-9a10-642e5a0a5d42> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:480a61f8-14b3-233e-8e5f-7f0db9696a1e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:480a61f8-14b3-233e-8e5f-7f0db9696a1e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:bee486c4-6ab5-6293-4114-d4be24f303d3"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:bee486c4-6ab5-6293-4114-d4be24f303d3> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:99893d3c-520c-8d7b-6d73-f46b1a662201"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:99893d3c-520c-8d7b-6d73-f46b1a662201> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:b3254b8e-6fc3-88d3-7d38-0afcf13c4f67> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:c9b53a46-2f61-7b3f-5780-5f5c79a47f12"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:c9b53a46-2f61-7b3f-5780-5f5c79a47f12> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:d6f7de9d-57a5-6a2c-1c2f-0d65718860f2> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:75073965-82eb-407d-34cf-3a7767a38149"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:75073965-82eb-407d-34cf-3a7767a38149> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:18762cff-9e29-6e71-1184-e9202fee8cba"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:18762cff-9e29-6e71-1184-e9202fee8cba> ) # can have others ] [ fhir:fullUrl [ fhir:v "urn:uuid:559ffdc3-349b-a4a3-a651-ce2715f08d69"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:559ffdc3-349b-a4a3-a651-ce2715f08d69> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:7943795a-2abe-666f-545f-133e23b97119"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:7943795a-2abe-666f-545f-133e23b97119> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:73d9d304-a0b8-31b6-1165-346563b9305e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:73d9d304-a0b8-31b6-1165-346563b9305e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:31abea79-81da-17f8-9d8c-94e9bb75876e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:31abea79-81da-17f8-9d8c-94e9bb75876e> ) # can have others ] [ fhir:fullUrl [ fhir:v "urn:uuid:6b96124b-1a44-0b6b-6783-d6c49360230b"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:6b96124b-1a44-0b6b-6783-d6c49360230b> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:306637ec-1041-80e8-8e77-e7ca814253e1"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:306637ec-1041-80e8-8e77-e7ca814253e1> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:1b43a536-3c29-3427-0b93-e35866ef8495"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:1b43a536-3c29-3427-0b93-e35866ef8495> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:cf2f00df-971f-0bab-8768-4251b1ad0817"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:cf2f00df-971f-0bab-8768-4251b1ad0817> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:35fa7b97-98d3-35d3-5672-4ab1047d57fc"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:35fa7b97-98d3-35d3-5672-4ab1047d57fc> ) # can have others ] [ fhir:fullUrl [ fhir:v "urn:uuid:accb8802-4223-61e2-8c79-2282e22a2bb6"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:accb8802-4223-61e2-8c79-2282e22a2bb6> ) # can have others ] [ fhir:fullUrl [ fhir:v "urn:uuid:6a5354bf-602c-99f1-324b-0bb5f7e06cd5"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:6a5354bf-602c-99f1-324b-0bb5f7e06cd5> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:588a6787-0454-55ef-0b8a-4c8941b6976c"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:588a6787-0454-55ef-0b8a-4c8941b6976c> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:3b550915-4467-83d3-340f-9bd6d2857191"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:3b550915-4467-83d3-340f-9bd6d2857191> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:930c7f69-2546-7148-2069-b3be3a755edf"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:930c7f69-2546-7148-2069-b3be3a755edf> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:b1726ce3-8bb5-403e-2e9b-f5d79cc716f9"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:b1726ce3-8bb5-403e-2e9b-f5d79cc716f9> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:8070745c-30c4-a52e-41fd-600a913578d4"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:8070745c-30c4-a52e-41fd-600a913578d4> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:7aa5fdea-17d7-29f1-1ed4-5c05eb62285a"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:7aa5fdea-17d7-29f1-1ed4-5c05eb62285a> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:872a645f-120e-44c0-62c0-9be05acf543b"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:872a645f-120e-44c0-62c0-9be05acf543b> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:7c06a03c-9cf7-2e1b-a236-d60038f1439b"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:7c06a03c-9cf7-2e1b-a236-d60038f1439b> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:f16113fe-27e7-0aa2-6787-9415f5051900"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:f16113fe-27e7-0aa2-6787-9415f5051900> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:1b25eb25-9149-02f6-9676-c87f90c64904"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:1b25eb25-9149-02f6-9676-c87f90c64904> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:004ed877-7729-834e-3b6b-a2cf4bdb2377"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:004ed877-7729-834e-3b6b-a2cf4bdb2377> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:b04c9321-069c-4da8-8ed0-86337ea22c30"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:b04c9321-069c-4da8-8ed0-86337ea22c30> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:f958e1e9-6023-4e39-2ffe-a9c8f135a2dd"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:f958e1e9-6023-4e39-2ffe-a9c8f135a2dd> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:62c1b1b4-8d15-26d2-57f9-25a2f60b6181"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:62c1b1b4-8d15-26d2-57f9-25a2f60b6181> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:6049d921-9935-90b7-4efc-894a66483c00"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:6049d921-9935-90b7-4efc-894a66483c00> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:2e3a85b5-790a-a108-3627-edf0ec6f1210"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:2e3a85b5-790a-a108-3627-edf0ec6f1210> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:e2359a4e-3091-23f8-2242-87e701830d55"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:e2359a4e-3091-23f8-2242-87e701830d55> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:a3fdc23b-6c16-2e65-481e-3fc895b37b87"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:a3fdc23b-6c16-2e65-481e-3fc895b37b87> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:cbcecab6-374c-396f-29be-877da7285e8d"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:cbcecab6-374c-396f-29be-877da7285e8d> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:ae1f3b4c-4f14-1460-6903-7260959ea2cd"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:ae1f3b4c-4f14-1460-6903-7260959ea2cd> ) ] ) . # Section 11 - Stability Study - Results <urn:uuid:54c8e8dc-9a19-0dc2-910e-d5a05d6ba003> a fhir:DiagnosticReport ; fhir:id [ fhir:v "studyResultsReport"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DiagnosticReport</b><a name=\"studyResultsReport\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource DiagnosticReport "studyResultsReport" </p></div><p><b>Triggered by</b>: <a href=\"#PlanDefinition_c3973835-10ca-0796-0a26-aa8afafc9c5b\">See above (PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b)</a></p><p><b>Extension - Statistical Model PQ</b>: information about statistical model utilized to interpret stability study results <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>Extension - Container Orientation PQ</b>: Horizontal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-containerOrientation-local-pq.html\">CodeSystem - Container Orientation</a>#horizontal "horizontal")</span></p><p><b>identifier</b>: id: PLO555</p><p><b>status</b>: final</p><p><b>code</b>: Stability Study Report <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-reportType-local-pq.html\">CodeSystem - Report Type</a>#Stability Study Report)</span></p><p><b>effective</b>: 2019-09-08</p><p><b>performer</b>: <a href=\"#Organization_6049d921-9935-90b7-4efc-894a66483c00\">See above (Organization/6049d921-9935-90b7-4efc-894a66483c00)</a></p><p><b>result</b>: </p><ul><li><a href=\"#Observation_588a6787-0454-55ef-0b8a-4c8941b6976c\">See above (Observation/588a6787-0454-55ef-0b8a-4c8941b6976c)</a></li><li><a href=\"#Observation_930c7f69-2546-7148-2069-b3be3a755edf\">See above (Observation/930c7f69-2546-7148-2069-b3be3a755edf)</a></li><li><a href=\"#Observation_8070745c-30c4-a52e-41fd-600a913578d4\">See above (Observation/8070745c-30c4-a52e-41fd-600a913578d4)</a></li><li><a href=\"#Observation_f16113fe-27e7-0aa2-6787-9415f5051900\">See above (Observation/f16113fe-27e7-0aa2-6787-9415f5051900)</a></li><li><a href=\"#Observation_1b25eb25-9149-02f6-9676-c87f90c64904\">See above (Observation/1b25eb25-9149-02f6-9676-c87f90c64904)</a></li><li><a href=\"#Observation_004ed877-7729-834e-3b6b-a2cf4bdb2377\">See above (Observation/004ed877-7729-834e-3b6b-a2cf4bdb2377)</a></li><li><a href=\"#Observation_f958e1e9-6023-4e39-2ffe-a9c8f135a2dd\">See above (Observation/f958e1e9-6023-4e39-2ffe-a9c8f135a2dd)</a></li></ul><p><b>conclusion</b>: The samples have been assessed and the conclusion is...</p></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b" ] # PlanDefinition\/stabilityStudyProtocol ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "information about statistical model utilized to interpret stability study results" ] # Want to use studyDesign, but problem is that this is CodeableConcept, which allows text. However when you use text, you then \n have no place to put a context. Ideally this would be a code\/code pair. \n Code says \"statistical model\", code (or text) then says what it is ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-containerOrientation-local-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "horizontal" ] ; fhir:display [ fhir:v "horizontal" ] ] ) ; fhir:text [ fhir:v "Horizontal" ] ] ] ) ; # fhir:identifier ( [ fhir:system [ fhir:v "https://eudract.europa.eu/example/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "PLO555" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Stability Study Report" ] ; fhir:display [ fhir:v "Stability Study Report" ] ] ) ] ; # fhir:effective [ fhir:v "2019-09-08"^^xsd:date ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-timePointDescription-local-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Delayed Start Code" ] ; fhir:display [ fhir:v "Delayed Start Code" ] ] ) ; fhir:text [ fhir:v "Refrigerated delayed testing" ] ] ] ) ] ; # fhir:performer ( [ fhir:reference [ fhir:v "Organization/6049d921-9935-90b7-4efc-894a66483c00" ] # Organization\/tester ] ) ; # fhir:result ( [ fhir:reference [ fhir:v "Observation/588a6787-0454-55ef-0b8a-4c8941b6976c" ] # Observation\/LongTerm30C-initial-1 ] [ fhir:reference [ fhir:v "Observation/930c7f69-2546-7148-2069-b3be3a755edf" ] # Observation\/LongTerm30C-Initial-2 ] [ fhir:reference [ fhir:v "Observation/8070745c-30c4-a52e-41fd-600a913578d4" ] # Observation\/LongTerm30C-Initial-3 ] [ fhir:reference [ fhir:v "Observation/f16113fe-27e7-0aa2-6787-9415f5051900" ] # Observation\/LongTerm30C-18m ] [ fhir:reference [ fhir:v "Observation/1b25eb25-9149-02f6-9676-c87f90c64904" ] # Observation\/LongTerm30C-18m-2 ] [ fhir:reference [ fhir:v "Observation/004ed877-7729-834e-3b6b-a2cf4bdb2377" ] # Observation\/LongTerm30C-18m-3 ] [ fhir:reference [ fhir:v "Observation/f958e1e9-6023-4e39-2ffe-a9c8f135a2dd" ] # Observation\/Accelerated40C-3m ] ) ; # fhir:conclusion [ fhir:v "The samples have been assessed and the conclusion is..."] . # <urn:uuid:c3973835-10ca-0796-0a26-aa8afafc9c5b> a fhir:PlanDefinition ; fhir:id [ fhir:v "c3973835-10ca-0796-0a26-aa8afafc9c5b"] ; # stabilityStudyProtocol fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"c3973835-10ca-0796-0a26-aa8afafc9c5b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition "c3973835-10ca-0796-0a26-aa8afafc9c5b" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b</code></p><p><b>title</b>: Stability Monitoring Program</p><p><b>type</b>: Stability Study Protocol <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (planType#1244588)</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"#SubstanceDefinition_2e3a85b5-790a-a108-3627-edf0ec6f1210\">See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)</a></p><p><b>description</b>: Description of the study study plan which includes tests, time points, storage conditions, method</p><blockquote><p><b>action</b></p><p><b>title</b>: Stability Test Protocol for Long-term and Accelerated Storage of Stelbatolol</p><blockquote><p><b>action</b></p><p><b>title</b>: Long-Term</p><p><b>description</b>: 30°C/65% RH</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Accelerated</p><p><b>description</b>: 40°C/75% RH</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b"^^xsd:anyURI] ; # http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b fhir:title [ fhir:v "Stability Monitoring Program"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://example.org/fhir/code/planType"^^xsd:anyURI ] ; fhir:code [ fhir:v "1244588" ] ; fhir:display [ fhir:v "Stability Study Protocol" ] ] ) ] ; # Added type (8/22/2023) fhir:status [ fhir:v "active"] ; # fhir:subject [ a fhir:Reference ; fhir:reference [ fhir:v "SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210" ] # SubstanceDefinition\/substance1 ] ; # fhir:description [ fhir:v "Description of the study study plan which includes tests, time points, storage conditions, method"] ; # unclear if want subject here, because it may apply to different ones , subjectCanonical value="MedicinalProductDefinition/product"/, this isn't followed at the moment, if it isnt in the file fhir:action ( [ fhir:title [ fhir:v "Stability Test Protocol for Long-term and Accelerated Storage of Stelbatolol" ] ; ( fhir:action [ fhir:title [ fhir:v "Long-Term" ] ; # TODO add codes here for the different levels? fhir:description [ fhir:v "30°C/65% RH" ] ; ( fhir:action [ fhir:title [ fhir:v "Initial" ] ; # 0 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "0"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "0"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "XY" ] ; # the categories to do at this step fhir:definition [ fhir:v "ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"^^xsd:anyURI ] # Long term , ActivityDefinition\/activityLongTerm30XY-Initial ] ) ] [ fhir:title [ fhir:v "3" ] ; # 3 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "3"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "3"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "X" ] ; fhir:definition [ fhir:v "ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e"^^xsd:anyURI ] # ActivityDefinition\/activityLongTerm30X-3 ] ) ] [ fhir:title [ fhir:v "6" ] ; # 6 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "6"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "6"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "X" ] ; fhir:definition [ fhir:v "ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3"^^xsd:anyURI ] # ActivityDefinition\/activityLongTerm30X-6 ] ) ] [ fhir:title [ fhir:v "9" ] ; # 9 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "9"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "9"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "X" ] ; fhir:definition [ fhir:v "ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201"^^xsd:anyURI ] # ActivityDefinition\/activityLongTerm30X-9 ] ) ] [ fhir:title [ fhir:v "12" ] ; # 12 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "12"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "12"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "X" ] ; fhir:definition [ fhir:v "ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"^^xsd:anyURI ] # ActivityDefinition\/activityLongTerm30X-12 ] ) ] [ fhir:title [ fhir:v "18" ] ; # 18 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "18"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "18"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "X" ] ; fhir:definition [ fhir:v "ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"^^xsd:anyURI ] # ActivityDefinition\/activityLongTerm30X-18 ] ) ] [ fhir:title [ fhir:v "24" ] ; # 24 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "24"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "24"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "X" ] ; fhir:definition [ fhir:v "ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"^^xsd:anyURI ] # ActivityDefinition\/activityLongTerm30X-24 ] ) ] [ fhir:title [ fhir:v "36" ] ; fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "36"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "36"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "(X)" ] ; fhir:requiredBehavior [ fhir:v "could" ] ; fhir:definition [ fhir:v "ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149"^^xsd:anyURI ] # ActivityDefinition\/activityLongTerm30X-36 ] ) ] ) ] [ fhir:title [ fhir:v "Accelerated" ] ; fhir:description [ fhir:v "40°C/75% RH" ] ; ( fhir:action [ fhir:title [ fhir:v "Initial" ] ; # 0 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "0"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "0"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "XY" ] ; # second category at this step fhir:definition [ fhir:v "ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495"^^xsd:anyURI ] # ActivityDefinition\/activityAccelerated40XY-Initial ] ) ] [ fhir:title [ fhir:v "3" ] ; # 3 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "3"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "3"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "X" ] ; fhir:definition [ fhir:v "ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"^^xsd:anyURI ] # ActivityDefinition\/activityAccelerated40X-3 ] ) ] [ fhir:title [ fhir:v "6" ] ; # 6 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "6"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "6"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "X" ] ; fhir:definition [ fhir:v "ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817"^^xsd:anyURI ] # ActivityDefinition\/activityAccelerated40X-6 ] ) ] [ fhir:title [ fhir:v "9" ] ; # 9 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "9"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "9"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "-" ] # none ] ) ] [ fhir:title [ fhir:v "12" ] ; # 12 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "12"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "12"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "-" ] # none ] ) ] [ fhir:title [ fhir:v "18" ] ; # 18 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "18"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "18"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "-" ] # none ] ) ] [ fhir:title [ fhir:v "24" ] ; # 24 months fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "24"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "24"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "-" ] # none ] ) ] [ fhir:title [ fhir:v "36" ] ; fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "36"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "36"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "-" ] ] ) ] ) ] ) ] ) . # end of accelerated <urn:uuid:643d8b44-71f4-2b58-07e8-51c22b294b25> a fhir:SpecimenDefinition ; fhir:id [ fhir:v "643d8b44-71f4-2b58-07e8-51c22b294b25"] ; # specimenDefStoredAt30 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SpecimenDefinition</b><a name=\"643d8b44-71f4-2b58-07e8-51c22b294b25\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SpecimenDefinition "643d8b44-71f4-2b58-07e8-51c22b294b25" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25</code></p><p><b>status</b>: active</p><blockquote><p><b>typeTested</b></p><p><b>preference</b>: preferred</p><h3>Handlings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Instruction</b></td></tr><tr><td style=\"display: none\">*</td><td>30°C/65% RH</td></tr></table></blockquote></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25"^^xsd:anyURI] ; # <meta> # <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq"/> # </meta>, http://example-server.com/fhir/SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25 fhir:status [ fhir:v "active"] ; # fhir:typeTested ( [ fhir:preference [ fhir:v "preferred" ] ; ( fhir:handling [ fhir:instruction [ fhir:v "30°C/65% RH" ] ] ) # easier than temp range? which doesnt have humidity ] ) . # <urn:uuid:10d7b693-7a0e-2f71-9a10-642e5a0a5d42> a fhir:ActivityDefinition ; fhir:id [ fhir:v "10d7b693-7a0e-2f71-9a10-642e5a0a5d42"] ; # activityLongTerm30XY-Initial fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"10d7b693-7a0e-2f71-9a10-642e5a0a5d42\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "10d7b693-7a0e-2f71-9a10-642e5a0a5d42" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42</code></p><p><b>title</b>: Long-term - 30°C/65% RH - XY</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba\">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a>, <a href=\"http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e\">http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42 fhir:title [ fhir:v "Long-term - 30°C/65% RH - XY"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba> ] [ fhir:v "http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e> ] ) . # ObservationDefinition/longTerm30X <urn:uuid:480a61f8-14b3-233e-8e5f-7f0db9696a1e> a fhir:ActivityDefinition ; fhir:id [ fhir:v "480a61f8-14b3-233e-8e5f-7f0db9696a1e"] ; # activityLongTerm30X-3 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"480a61f8-14b3-233e-8e5f-7f0db9696a1e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "480a61f8-14b3-233e-8e5f-7f0db9696a1e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba\">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e fhir:title [ fhir:v "Long-term - 30°C/65% RH - X"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba> ] ) . # ObservationDefinition/longTerm30X <urn:uuid:bee486c4-6ab5-6293-4114-d4be24f303d3> a fhir:ActivityDefinition ; fhir:id [ fhir:v "bee486c4-6ab5-6293-4114-d4be24f303d3"] ; # activityLongTerm30X-6 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"bee486c4-6ab5-6293-4114-d4be24f303d3\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "bee486c4-6ab5-6293-4114-d4be24f303d3" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba\">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3 fhir:title [ fhir:v "Long-term - 30°C/65% RH - X"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba> ] ) . # ObservationDefinition/longTerm30X <urn:uuid:99893d3c-520c-8d7b-6d73-f46b1a662201> a fhir:ActivityDefinition ; fhir:id [ fhir:v "99893d3c-520c-8d7b-6d73-f46b1a662201"] ; # activityLongTerm30X-9 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"99893d3c-520c-8d7b-6d73-f46b1a662201\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "99893d3c-520c-8d7b-6d73-f46b1a662201" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba\">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201 fhir:title [ fhir:v "Long-term - 30°C/65% RH - X"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba> ] ) . # ObservationDefinition/longTerm30X <urn:uuid:b3254b8e-6fc3-88d3-7d38-0afcf13c4f67> a fhir:ActivityDefinition ; fhir:id [ fhir:v "b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"] ; # activityLongTerm30X-12 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"b3254b8e-6fc3-88d3-7d38-0afcf13c4f67\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "b3254b8e-6fc3-88d3-7d38-0afcf13c4f67" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba\">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67 fhir:title [ fhir:v "Long-term - 30°C/65% RH - X"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba> ] ) . # ObservationDefinition/longTerm30X <urn:uuid:c9b53a46-2f61-7b3f-5780-5f5c79a47f12> a fhir:ActivityDefinition ; fhir:id [ fhir:v "c9b53a46-2f61-7b3f-5780-5f5c79a47f12"] ; # activityLongTerm30X-18 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"c9b53a46-2f61-7b3f-5780-5f5c79a47f12\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "c9b53a46-2f61-7b3f-5780-5f5c79a47f12" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba\">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12 fhir:title [ fhir:v "Long-term - 30°C/65% RH - X"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba> ] ) . # ObservationDefinition/longTerm30X <urn:uuid:d6f7de9d-57a5-6a2c-1c2f-0d65718860f2> a fhir:ActivityDefinition ; fhir:id [ fhir:v "d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"] ; # activityLongTerm30X-24 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"d6f7de9d-57a5-6a2c-1c2f-0d65718860f2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "d6f7de9d-57a5-6a2c-1c2f-0d65718860f2" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba\">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2 fhir:title [ fhir:v "Long-term - 30°C/65% RH - X"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba> ] ) . # ObservationDefinition/longTerm30X <urn:uuid:75073965-82eb-407d-34cf-3a7767a38149> a fhir:ActivityDefinition ; fhir:id [ fhir:v "75073965-82eb-407d-34cf-3a7767a38149"] ; # activityLongTerm30X-36 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"75073965-82eb-407d-34cf-3a7767a38149\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "75073965-82eb-407d-34cf-3a7767a38149" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba\">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149 fhir:title [ fhir:v "Long-term - 30°C/65% RH - X"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba> ] ) . # ObservationDefinition/longTerm30X <urn:uuid:18762cff-9e29-6e71-1184-e9202fee8cba> a fhir:ObservationDefinition ; fhir:id [ fhir:v "18762cff-9e29-6e71-1184-e9202fee8cba"] ; # longTerm30X fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"18762cff-9e29-6e71-1184-e9202fee8cba\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "18762cff-9e29-6e71-1184-e9202fee8cba" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</code></p><p><b>title</b>: X</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'X' at 30°C/65% RH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_643d8b44-71f4-2b58-07e8-51c22b294b25\">See above (SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25)</a></p><p><b>hasMember</b>: </p><ul><li><a href=\"#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></li><li><a href=\"#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></li><li><a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></li></ul></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"^^xsd:anyURI] ; # <meta> # <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/> # </meta>, http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba fhir:title [ fhir:v "X"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ fhir:text [ fhir:v "Battery of tests 'X' at 30°C/65% RH" ] ] ; # fhir:specimen ( [ fhir:reference [ fhir:v "SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25" ] # SpecimenDefinition\/specimenDefStoredAt30 ] ) ; # fhir:hasMember ( [ fhir:reference [ fhir:v "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69" ] # ObservationDefinition\/Description ] [ fhir:reference [ fhir:v "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119" ] # ObservationDefinition\/Assay ] [ fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ) . # <urn:uuid:559ffdc3-349b-a4a3-a651-ce2715f08d69> a fhir:ObservationDefinition ; fhir:id [ fhir:v "559ffdc3-349b-a4a3-a651-ce2715f08d69"] ; # Description fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"559ffdc3-349b-a4a3-a651-ce2715f08d69\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "559ffdc3-349b-a4a3-a651-ce2715f08d69" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 fhir:title [ fhir:v "Description"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DESC" ] ; fhir:display [ fhir:v "Description" ] ] ) ; fhir:text [ fhir:v "Description" ] ] ; # fhir:qualifiedValue ( [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "A white to brown powder" ] ] ) ] ) . # <urn:uuid:7943795a-2abe-666f-545f-133e23b97119> a fhir:ObservationDefinition ; fhir:id [ fhir:v "7943795a-2abe-666f-545f-133e23b97119"] ; # Assay fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"7943795a-2abe-666f-545f-133e23b97119\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "7943795a-2abe-666f-545f-133e23b97119" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</code></p><p><b>title</b>: Assay (% w/w) (Mean)</p><p><b>status</b>: active</p><p><b>code</b>: Assay (% w/w) (Mean) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY "Assay")</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>98-102 % w/w</td></tr></table></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 fhir:title [ fhir:v "Assay (% w/w) (Mean)"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] ) ; fhir:text [ fhir:v "Assay (% w/w) (Mean)" ] ] ; # fhir:qualifiedValue ( [ fhir:range [ fhir:low [ fhir:value [ fhir:v "98"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; fhir:high [ fhir:value [ fhir:v "102"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] ] ) . # <urn:uuid:73d9d304-a0b8-31b6-1165-346563b9305e> a fhir:ObservationDefinition ; fhir:id [ fhir:v "73d9d304-a0b8-31b6-1165-346563b9305e"] ; # Impurities fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"73d9d304-a0b8-31b6-1165-346563b9305e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "73d9d304-a0b8-31b6-1165-346563b9305e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</code></p><p><b>title</b>: Drug-related Impurities Content by LC (% w/w)</p><p><b>status</b>: active</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.52</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.10</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.0</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e fhir:title [ fhir:v "Drug-related Impurities Content by LC (% w/w)"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ] ; # fhir:qualifiedValue ( [ ( fhir:appliesTo [ fhir:text [ fhir:v "Impurity" ] # could be a code ] ) ; fhir:range [ fhir:high [ fhir:value [ fhir:v "0.5"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] ] [ ( fhir:appliesTo [ fhir:text [ fhir:v "Impurity 2" ] ] ) ; fhir:range [ fhir:high [ fhir:value [ fhir:v "0.52"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] ] [ ( fhir:appliesTo [ fhir:text [ fhir:v "Any Unspecified Impurity" ] ] ) ; fhir:range [ fhir:high [ fhir:value [ fhir:v "0.10"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] ] [ ( fhir:appliesTo [ fhir:text [ fhir:v "Total Impurities" ] ] ) ; fhir:range [ fhir:high [ fhir:value [ fhir:v "2.0"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] ] ) ; # fhir:component ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] # are expected to have a component that says what impurity this one is ] ) . # <urn:uuid:31abea79-81da-17f8-9d8c-94e9bb75876e> a fhir:ObservationDefinition ; fhir:id [ fhir:v "31abea79-81da-17f8-9d8c-94e9bb75876e"] ; # longTerm30Y fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"31abea79-81da-17f8-9d8c-94e9bb75876e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "31abea79-81da-17f8-9d8c-94e9bb75876e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e</code></p><p><b>title</b>: Y</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Y' at 30°C/65% RH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_643d8b44-71f4-2b58-07e8-51c22b294b25\">See above (SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25)</a></p><p><b>hasMember</b>: <a href=\"#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e"^^xsd:anyURI] ; # <meta> # <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/> # </meta>, http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e fhir:title [ fhir:v "Y"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ fhir:text [ fhir:v "Battery of tests 'Y' at 30°C/65% RH" ] ] ; # fhir:specimen ( [ fhir:reference [ fhir:v "SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25" ] # SpecimenDefinition\/specimenDefStoredAt30 ] ) ; # fhir:hasMember ( [ fhir:reference [ fhir:v "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b" ] # ObservationDefinition\/Identification ] ) . # <urn:uuid:6b96124b-1a44-0b6b-6783-d6c49360230b> a fhir:ObservationDefinition ; fhir:id [ fhir:v "6b96124b-1a44-0b6b-6783-d6c49360230b"] ; # Identification fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"6b96124b-1a44-0b6b-6783-d6c49360230b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "6b96124b-1a44-0b6b-6783-d6c49360230b" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b fhir:title [ fhir:v "Identification"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IDT" ] ; fhir:display [ fhir:v "Identification" ] ] ) ; fhir:text [ fhir:v "Identification" ] ] ; # fhir:qualifiedValue ( [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "Complies" ] ] ) ] ) . # <urn:uuid:306637ec-1041-80e8-8e77-e7ca814253e1> a fhir:SpecimenDefinition ; fhir:id [ fhir:v "306637ec-1041-80e8-8e77-e7ca814253e1"] ; # specimenDefStoredAt40 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SpecimenDefinition</b><a name=\"306637ec-1041-80e8-8e77-e7ca814253e1\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SpecimenDefinition "306637ec-1041-80e8-8e77-e7ca814253e1" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1</code></p><p><b>status</b>: active</p><blockquote><p><b>typeTested</b></p><p><b>preference</b>: preferred</p><h3>Handlings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Instruction</b></td></tr><tr><td style=\"display: none\">*</td><td>40°C/75% RH</td></tr></table></blockquote></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1"^^xsd:anyURI] ; # <meta> # <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq"/> # </meta>, http://example-server.com/fhir/SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1 fhir:status [ fhir:v "active"] ; # fhir:typeTested ( [ fhir:preference [ fhir:v "preferred" ] ; ( fhir:handling [ fhir:instruction [ fhir:v "40°C/75% RH" ] ] ) ] ) . # <urn:uuid:1b43a536-3c29-3427-0b93-e35866ef8495> a fhir:ActivityDefinition ; fhir:id [ fhir:v "1b43a536-3c29-3427-0b93-e35866ef8495"] ; # activityAccelerated40XY-Initial fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"1b43a536-3c29-3427-0b93-e35866ef8495\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "1b43a536-3c29-3427-0b93-e35866ef8495" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - XY</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc\">http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc</a>, <a href=\"http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6\">http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495 fhir:title [ fhir:v "Accelerated - 40°C/70% RH - XY"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc> ] [ fhir:v "http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6> ] ) . # ObservationDefinition/accelerated40X <urn:uuid:8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9> a fhir:ActivityDefinition ; fhir:id [ fhir:v "8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"] ; # activityAccelerated40X-3 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc\">http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9 fhir:title [ fhir:v "Accelerated - 40°C/70% RH - X"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc> ] ) . # ObservationDefinition/accelerated40X <urn:uuid:cf2f00df-971f-0bab-8768-4251b1ad0817> a fhir:ActivityDefinition ; fhir:id [ fhir:v "cf2f00df-971f-0bab-8768-4251b1ad0817"] ; # activityAccelerated40X-6 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"cf2f00df-971f-0bab-8768-4251b1ad0817\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "cf2f00df-971f-0bab-8768-4251b1ad0817" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc\">http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817"^^xsd:anyURI] ; # http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817 fhir:title [ fhir:v "Accelerated - 40°C/70% RH - X"] ; # fhir:status [ fhir:v "active"] ; # fhir:observationRequirement ( [ fhir:v "http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc> ] ) . # ObservationDefinition/accelerated40X <urn:uuid:35fa7b97-98d3-35d3-5672-4ab1047d57fc> a fhir:ObservationDefinition ; fhir:id [ fhir:v "35fa7b97-98d3-35d3-5672-4ab1047d57fc"] ; # accelerated40X fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"35fa7b97-98d3-35d3-5672-4ab1047d57fc\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "35fa7b97-98d3-35d3-5672-4ab1047d57fc" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc</code></p><p><b>title</b>: X</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'X' at 40°C/75% RH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_306637ec-1041-80e8-8e77-e7ca814253e1\">See above (SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1)</a></p><p><b>hasMember</b>: </p><ul><li><a href=\"#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></li><li><a href=\"#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></li></ul></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc fhir:title [ fhir:v "X"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ fhir:text [ fhir:v "Battery of tests 'X' at 40°C/75% RH" ] ] ; # fhir:specimen ( [ fhir:reference [ fhir:v "SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1" ] # SpecimenDefinition\/specimenDefStoredAt40 ] ) ; # fhir:hasMember ( [ fhir:reference [ fhir:v "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69" ] # ObservationDefinition\/Description ] [ fhir:reference [ fhir:v "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119" ] # ObservationDefinition\/Assay ] ) . # <urn:uuid:accb8802-4223-61e2-8c79-2282e22a2bb6> a fhir:ObservationDefinition ; fhir:id [ fhir:v "accb8802-4223-61e2-8c79-2282e22a2bb6"] ; # accelerated40Y fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"accb8802-4223-61e2-8c79-2282e22a2bb6\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "accb8802-4223-61e2-8c79-2282e22a2bb6" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6</code></p><p><b>title</b>: Y</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Y' at 40°C/75% RH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_306637ec-1041-80e8-8e77-e7ca814253e1\">See above (SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1)</a></p><p><b>hasMember</b>: <a href=\"#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6 fhir:title [ fhir:v "Y"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ fhir:text [ fhir:v "Battery of tests 'Y' at 40°C/75% RH" ] ] ; # fhir:specimen ( [ fhir:reference [ fhir:v "SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1" ] # SpecimenDefinition\/specimenDefStoredAt40 ] ) ; # fhir:hasMember ( [ fhir:reference [ fhir:v "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b" ] # ObservationDefinition\/Identification ] ) . # <urn:uuid:6a5354bf-602c-99f1-324b-0bb5f7e06cd5> a fhir:Specimen ; fhir:id [ fhir:v "6a5354bf-602c-99f1-324b-0bb5f7e06cd5"] ; # stabilityInitial-1 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"6a5354bf-602c-99f1-324b-0bb5f7e06cd5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "6a5354bf-602c-99f1-324b-0bb5f7e06cd5" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>" ] ; # fhir:collection [ fhir:collected [ fhir:v "2020-06"^^xsd:gYearMonth ] ] ; # when sample first taken, before the timed periods start fhir:processing ( [ fhir:description [ fhir:v "No storage" ] ] [ fhir:description [ fhir:v "25°C/60% RH" ] ] ) . # <urn:uuid:588a6787-0454-55ef-0b8a-4c8941b6976c> a fhir:Observation ; fhir:id [ fhir:v "588a6787-0454-55ef-0b8a-4c8941b6976c"] ; # LongTerm30C-initial-1 fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"588a6787-0454-55ef-0b8a-4c8941b6976c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "588a6787-0454-55ef-0b8a-4c8941b6976c" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_10d7b693-7a0e-2f71-9a10-642e5a0a5d42\">See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href=\"#Specimen_6a5354bf-602c-99f1-324b-0bb5f7e06cd5\">See above (Specimen/6a5354bf-602c-99f1-324b-0bb5f7e06cd5)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm30C-initial-1-Description\"> </a></li><li><a name=\"LongTerm30C-initial-1-Assay\"> </a></li><li><a name=\"LongTerm30C-initial-1-Impurity1\"> </a></li><li><a name=\"LongTerm30C-initial-1-Impurity2\"> </a></li><li><a name=\"LongTerm30C-initial-1-ImpurityUnspecified\"> </a></li><li><a name=\"LongTerm30C-initial-1-ImpurityTotal\"> </a></li><li><a name=\"LongTerm30C-initial-1-Identification\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm30C-initial-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-1-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.15 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-1-Impurity1\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-1-Impurity2\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-1-ImpurityUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.05 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-1-ImpurityTotal\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.8 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-1-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-Description</b><a name=\"LongTerm30C-initial-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-Impurity1</b><a name=\"LongTerm30C-initial-1-Impurity1\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-Impurity2</b><a name=\"LongTerm30C-initial-1-Impurity2\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-ImpurityUnspecified</b><a name=\"LongTerm30C-initial-1-ImpurityUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.05 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-ImpurityTotal</b><a name=\"LongTerm30C-initial-1-ImpurityTotal\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.8 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-Assay</b><a name=\"LongTerm30C-initial-1-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.15 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-Identification</b><a name=\"LongTerm30C-initial-1-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>" ] ; # fhir:contained ( [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-1-Description" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69" ] # ObservationDefinition\/Description ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DESC" ] ; fhir:display [ fhir:v "Description" ] ] ) ; fhir:text [ fhir:v "Description" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-1-Impurity1" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DGP" ] ; fhir:display [ fhir:v "Degradation Products" ] ] ) ; fhir:text [ fhir:v "Degradation Products" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.1"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity" ] # could have the code of an impurity substance, or could have an extension to point to it as a resource ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-1-Impurity2" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.2"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity 2" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-1-ImpurityUnspecified" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.05"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<" ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Any Unspecified Impurity" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-1-ImpurityTotal" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.8"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Total Impurities" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-1-Assay" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119" ] # ObservationDefinition\/Assay ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] ) ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.15"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-1-Identification" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b" ] # ObservationDefinition\/Identification ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IDT" ] ; fhir:display [ fhir:v "Identification" ] ] ) ; fhir:text [ fhir:v "Identification" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] ) ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42" ] # ActivityDefinition\/activityLongTerm30XY-Initial ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:code [ fhir:text [ fhir:v "Test Components - Long-term 25C etc - Initial (XYZ)" ] ] ; # fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; # fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime] ; # fhir:performer ( [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; # fhir:specimen [ fhir:reference [ fhir:v "Specimen/6a5354bf-602c-99f1-324b-0bb5f7e06cd5" ] # Specimen\/stabilityInitial-1 ] ; # fhir:hasMember ( [ fhir:reference [ fhir:v "#LongTerm30C-initial-1-Description" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-1-Assay" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-1-Impurity1" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-1-Impurity2" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-1-ImpurityUnspecified" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-1-ImpurityTotal" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-1-Identification" ] ] ) . # <urn:uuid:3b550915-4467-83d3-340f-9bd6d2857191> a fhir:Specimen ; fhir:id [ fhir:v "3b550915-4467-83d3-340f-9bd6d2857191"] ; # stabilityInitial-2 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"3b550915-4467-83d3-340f-9bd6d2857191\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "3b550915-4467-83d3-340f-9bd6d2857191" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>" ] ; # fhir:collection [ fhir:collected [ fhir:v "2020-06"^^xsd:gYearMonth ] ] ; # when sample first taken, before the timed periods start fhir:processing ( [ fhir:description [ fhir:v "No storage" ] ] [ fhir:description [ fhir:v "25°C/60% RH" ] ] ) . # <urn:uuid:930c7f69-2546-7148-2069-b3be3a755edf> a fhir:Observation ; fhir:id [ fhir:v "930c7f69-2546-7148-2069-b3be3a755edf"] ; # LongTerm30C-Initial-2 fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"930c7f69-2546-7148-2069-b3be3a755edf\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "930c7f69-2546-7148-2069-b3be3a755edf" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_10d7b693-7a0e-2f71-9a10-642e5a0a5d42\">See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href=\"#Specimen_3b550915-4467-83d3-340f-9bd6d2857191\">See above (Specimen/3b550915-4467-83d3-340f-9bd6d2857191)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm30C-initial-2-Description\"> </a></li><li><a name=\"LongTerm30C-initial-2-Assay\"> </a></li><li><a name=\"LongTerm30C-initial-2-Degradation-imp1\"> </a></li><li><a name=\"LongTerm30C-initial-2-Degradation-imp2\"> </a></li><li><a name=\"LongTerm30C-initial-2-Degradation-impUnspecified\"> </a></li><li><a name=\"LongTerm30C-initial-2-Degradation-impTotal\"> </a></li><li><a name=\"LongTerm30C-initial-2-Identification\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm30C-initial-2-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-2-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.152 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-2-Degradation-imp1\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.12 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-2-Degradation-imp2\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.22 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-2-Degradation-impUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.052 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-2-Degradation-impTotal\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.82 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-2-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Does not comply <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Description</b><a name=\"LongTerm30C-initial-2-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-imp1</b><a name=\"LongTerm30C-initial-2-Degradation-imp1\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.12 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-imp2</b><a name=\"LongTerm30C-initial-2-Degradation-imp2\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.22 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-impUnspecified</b><a name=\"LongTerm30C-initial-2-Degradation-impUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.052 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-impTotal</b><a name=\"LongTerm30C-initial-2-Degradation-impTotal\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.82 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Assay</b><a name=\"LongTerm30C-initial-2-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.152 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Identification</b><a name=\"LongTerm30C-initial-2-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Does not comply <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>" ] ; # fhir:contained ( [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-2-Description" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69" ] # ObservationDefinition\/Description ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DESC" ] ; fhir:display [ fhir:v "Description" ] ] ) ; fhir:text [ fhir:v "Description" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-2-Degradation-imp1" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DGP" ] ; fhir:display [ fhir:v "Degradation Products" ] ] ) ; fhir:text [ fhir:v "Degradation Products" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.12"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity" ] # could have the code of an impurity substance, or could have an extension to point to it as a resource ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-2-Degradation-imp2" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.22"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity 2" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-2-Degradation-impUnspecified" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.052"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<" ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Any Unspecified Impurity" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-2-Degradation-impTotal" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.82"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Total Impurities" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-2-Assay" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119" ] # ObservationDefinition\/Assay ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] ) ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.152"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-2-Identification" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b" ] # ObservationDefinition\/Identification ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IDT" ] ; fhir:display [ fhir:v "Identification" ] ] ) ; fhir:text [ fhir:v "Identification" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Does not comply" ] ] ] ) ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42" ] # ActivityDefinition\/activityLongTerm30XY-Initial ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:code [ fhir:text [ fhir:v "Test Components - Long-term 25C etc - Initial (XYZ)" ] ] ; # fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; # fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime] ; # fhir:performer ( [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; # fhir:specimen [ fhir:reference [ fhir:v "Specimen/3b550915-4467-83d3-340f-9bd6d2857191" ] # Specimen\/stabilityInitial-2 ] ; # fhir:hasMember ( [ fhir:reference [ fhir:v "#LongTerm30C-initial-2-Description" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-2-Assay" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-2-Degradation-imp1" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-2-Degradation-imp2" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-2-Degradation-impUnspecified" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-2-Degradation-impTotal" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-2-Identification" ] ] ) . # <urn:uuid:b1726ce3-8bb5-403e-2e9b-f5d79cc716f9> a fhir:Specimen ; fhir:id [ fhir:v "b1726ce3-8bb5-403e-2e9b-f5d79cc716f9"] ; # stabilityInitial-3 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"b1726ce3-8bb5-403e-2e9b-f5d79cc716f9\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "b1726ce3-8bb5-403e-2e9b-f5d79cc716f9" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>" ] ; # fhir:collection [ fhir:collected [ fhir:v "2020-06"^^xsd:gYearMonth ] ] ; # when sample first taken, before the timed periods start fhir:processing ( [ fhir:description [ fhir:v "No storage" ] ] [ fhir:description [ fhir:v "25°C/60% RH" ] ] ) . # <urn:uuid:8070745c-30c4-a52e-41fd-600a913578d4> a fhir:Observation ; fhir:id [ fhir:v "8070745c-30c4-a52e-41fd-600a913578d4"] ; # LongTerm30C-Initial-3 fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"8070745c-30c4-a52e-41fd-600a913578d4\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "8070745c-30c4-a52e-41fd-600a913578d4" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_10d7b693-7a0e-2f71-9a10-642e5a0a5d42\">See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href=\"#Specimen_b1726ce3-8bb5-403e-2e9b-f5d79cc716f9\">See above (Specimen/b1726ce3-8bb5-403e-2e9b-f5d79cc716f9)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm30C-initial-3-Description\"> </a></li><li><a name=\"LongTerm30C-initial-3-Assay\"> </a></li><li><a name=\"LongTerm30C-initial-3-Degradation-imp1\"> </a></li><li><a name=\"LongTerm30C-initial-3-Degradation-imp2\"> </a></li><li><a name=\"LongTerm30C-initial-3-Degradation-impUnspecified\"> </a></li><li><a name=\"LongTerm30C-initial-3-Degradation-impTotal\"> </a></li><li><a name=\"LongTerm30C-initial-3-Identification\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm30C-initial-3-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-3-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.152 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-3-Degradation-imp1\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.12 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-3-Degradation-imp2\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.22 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-3-Degradation-impUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.052 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-3-Degradation-impTotal\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.82 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-initial-3-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Does not comply <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Description</b><a name=\"LongTerm30C-initial-3-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-imp1</b><a name=\"LongTerm30C-initial-3-Degradation-imp1\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.12 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-imp2</b><a name=\"LongTerm30C-initial-3-Degradation-imp2\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.22 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-impUnspecified</b><a name=\"LongTerm30C-initial-3-Degradation-impUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.052 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-impTotal</b><a name=\"LongTerm30C-initial-3-Degradation-impTotal\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.82 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Assay</b><a name=\"LongTerm30C-initial-3-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.152 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Identification</b><a name=\"LongTerm30C-initial-3-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Does not comply <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>" ] ; # fhir:contained ( [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-3-Description" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69" ] # ObservationDefinition\/Description ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DESC" ] ; fhir:display [ fhir:v "Description" ] ] ) ; fhir:text [ fhir:v "Description" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-3-Degradation-imp1" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DGP" ] ; fhir:display [ fhir:v "Degradation Products" ] ] ) ; fhir:text [ fhir:v "Degradation Products" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.12"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity" ] # could have the code of an impurity substance, or could have an extension to point to it as a resource ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-3-Degradation-imp2" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.22"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity 2" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-3-Degradation-impUnspecified" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.052"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<" ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Any Unspecified Impurity" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-3-Degradation-impTotal" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.82"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Total Impurities" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-3-Assay" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119" ] # ObservationDefinition\/Assay ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] ) ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.152"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-initial-3-Identification" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b" ] # ObservationDefinition\/Identification ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IDT" ] ; fhir:display [ fhir:v "Identification" ] ] ) ; fhir:text [ fhir:v "Identification" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Does not comply" ] ] ] ) ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42" ] # ActivityDefinition\/activityLongTerm30XY-Initial ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:code [ fhir:text [ fhir:v "Test Components - Long-term 25C etc - Initial (XYZ)" ] ] ; # fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; # fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime] ; # fhir:performer ( [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; # fhir:specimen [ fhir:reference [ fhir:v "Specimen/b1726ce3-8bb5-403e-2e9b-f5d79cc716f9" ] # Specimen\/stabilityInitial-3 ] ; # fhir:hasMember ( [ fhir:reference [ fhir:v "#LongTerm30C-initial-3-Description" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-3-Assay" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-3-Degradation-imp1" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-3-Degradation-imp2" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-3-Degradation-impUnspecified" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-3-Degradation-impTotal" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-initial-3-Identification" ] ] ) . # <urn:uuid:7aa5fdea-17d7-29f1-1ed4-5c05eb62285a> a fhir:Specimen ; fhir:id [ fhir:v "7aa5fdea-17d7-29f1-1ed4-5c05eb62285a"] ; # stability18months-1 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"7aa5fdea-17d7-29f1-1ed4-5c05eb62285a\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "7aa5fdea-17d7-29f1-1ed4-5c05eb62285a" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 30°C/65% RH</p></blockquote></div>" ] ; # fhir:collection [ fhir:collected [ fhir:v "2020-06"^^xsd:gYearMonth ] ] ; # fhir:processing ( [ fhir:description [ fhir:v "Store for 18 months" ] ; fhir:time [ a fhir:Period ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Duration ; fhir:value [ fhir:v "18"^^xsd:decimal ] ; fhir:unit [ fhir:v "month" ] ] ] ) ; fhir:start [ fhir:v "2020-12"^^xsd:gYearMonth ] ; fhir:end [ fhir:v "2022-06"^^xsd:gYearMonth ] ] ] [ fhir:description [ fhir:v "30°C/65% RH" ] ] ) . # <urn:uuid:872a645f-120e-44c0-62c0-9be05acf543b> a fhir:Specimen ; fhir:id [ fhir:v "872a645f-120e-44c0-62c0-9be05acf543b"] ; # stability18months-2 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"872a645f-120e-44c0-62c0-9be05acf543b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "872a645f-120e-44c0-62c0-9be05acf543b" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 30°C/65% RH</p></blockquote></div>" ] ; # fhir:collection [ fhir:collected [ fhir:v "2020-06"^^xsd:gYearMonth ] ] ; # fhir:processing ( [ fhir:description [ fhir:v "Store for 18 months" ] ; fhir:time [ a fhir:Period ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Duration ; fhir:value [ fhir:v "18"^^xsd:decimal ] ; fhir:unit [ fhir:v "month" ] ] ] ) ; fhir:start [ fhir:v "2020-12"^^xsd:gYearMonth ] ; fhir:end [ fhir:v "2022-06"^^xsd:gYearMonth ] ] ] [ fhir:description [ fhir:v "30°C/65% RH" ] ] ) . # <urn:uuid:7c06a03c-9cf7-2e1b-a236-d60038f1439b> a fhir:Specimen ; fhir:id [ fhir:v "7c06a03c-9cf7-2e1b-a236-d60038f1439b"] ; # stability18months-3 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"7c06a03c-9cf7-2e1b-a236-d60038f1439b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "7c06a03c-9cf7-2e1b-a236-d60038f1439b" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 30°C/65% RH</p></blockquote></div>" ] ; # fhir:collection [ fhir:collected [ fhir:v "2020-06"^^xsd:gYearMonth ] ] ; # fhir:processing ( [ fhir:description [ fhir:v "Store for 18 months" ] ; fhir:time [ a fhir:Period ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Duration ; fhir:value [ fhir:v "18"^^xsd:decimal ] ; fhir:unit [ fhir:v "month" ] ] ] ) ; fhir:start [ fhir:v "2020-12"^^xsd:gYearMonth ] ; fhir:end [ fhir:v "2022-06"^^xsd:gYearMonth ] ] ] [ fhir:description [ fhir:v "30°C/65% RH" ] ] ) . # <urn:uuid:f16113fe-27e7-0aa2-6787-9415f5051900> a fhir:Observation ; fhir:id [ fhir:v "f16113fe-27e7-0aa2-6787-9415f5051900"] ; # LongTerm30C-18m fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"f16113fe-27e7-0aa2-6787-9415f5051900\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "f16113fe-27e7-0aa2-6787-9415f5051900" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_c9b53a46-2f61-7b3f-5780-5f5c79a47f12\">See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)</a></p><p><b>status</b>: final</p><p><b>code</b>: Long-term - 30°C/65% RH - 18 months (X) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href=\"#Specimen_7aa5fdea-17d7-29f1-1ed4-5c05eb62285a\">See above (Specimen/7aa5fdea-17d7-29f1-1ed4-5c05eb62285a)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm30C-18m-1-Description\"> </a></li><li><a name=\"LongTerm30C-18m-1-Assay\"> </a></li><li><a name=\"LongTerm30C-18m-1-Impurity1\"> </a></li><li><a name=\"LongTerm30C-18m-1-Impurity2\"> </a></li><li><a name=\"LongTerm30C-18m-1-ImpurityUnspecified\"> </a></li><li><a name=\"LongTerm30C-18m-1-ImpurityTotal\"> </a></li><li><a name=\"LongTerm30C-18m-1-Identification\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm30C-18m-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-1-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-1-Impurity1\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-1-Impurity2\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.218 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-1-ImpurityUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.0518 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-1-ImpurityTotal\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.818 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-1-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-Description</b><a name=\"LongTerm30C-18m-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-Impurity1</b><a name=\"LongTerm30C-18m-1-Impurity1\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-Impurity2</b><a name=\"LongTerm30C-18m-1-Impurity2\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.218 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-ImpurityUnspecified</b><a name=\"LongTerm30C-18m-1-ImpurityUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.0518 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-ImpurityTotal</b><a name=\"LongTerm30C-18m-1-ImpurityTotal\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.818 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-Assay</b><a name=\"LongTerm30C-18m-1-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-Identification</b><a name=\"LongTerm30C-18m-1-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>" ] ; # fhir:contained ( [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-1-Description" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69" ] # ObservationDefinition\/Description ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DESC" ] ; fhir:display [ fhir:v "Description" ] ] ) ; fhir:text [ fhir:v "Description" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-1-Impurity1" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DGP" ] ; fhir:display [ fhir:v "Degradation Products" ] ] ) ; fhir:text [ fhir:v "Degradation Products" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.118"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity" ] # could have the code of an impurity substance, or could have an extension to point to it as a resource ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-1-Impurity2" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.218"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity 2" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-1-ImpurityUnspecified" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.0518"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<" ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Any Unspecified Impurity" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-1-ImpurityTotal" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.818"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Total Impurities" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-1-Assay" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119" ] # ObservationDefinition\/Assay ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] ) ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.118"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-1-Identification" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b" ] # ObservationDefinition\/Identification ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IDT" ] ; fhir:display [ fhir:v "Identification" ] ] ) ; fhir:text [ fhir:v "Identification" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] ) ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12" ] # ActivityDefinition\/activityLongTerm30X-18 ] ] ) ; # use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan # that would mean using sub-ActivityDefintions probably fhir:status [ fhir:v "final"] ; # fhir:code [ fhir:text [ fhir:v "Long-term - 30°C/65% RH - 18 months (X)" ] ] ; # fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; # fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime] ; # fhir:performer ( [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; # fhir:specimen [ fhir:reference [ fhir:v "Specimen/7aa5fdea-17d7-29f1-1ed4-5c05eb62285a" ] # Specimen\/stability18months-1 ] ; # fhir:hasMember ( [ fhir:reference [ fhir:v "#LongTerm30C-18m-1-Description" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-1-Assay" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-1-Impurity1" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-1-Impurity2" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-1-ImpurityUnspecified" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-1-ImpurityTotal" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-1-Identification" ] ] ) . # <urn:uuid:1b25eb25-9149-02f6-9676-c87f90c64904> a fhir:Observation ; fhir:id [ fhir:v "1b25eb25-9149-02f6-9676-c87f90c64904"] ; # LongTerm30C-18m-2 fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"1b25eb25-9149-02f6-9676-c87f90c64904\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "1b25eb25-9149-02f6-9676-c87f90c64904" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_c9b53a46-2f61-7b3f-5780-5f5c79a47f12\">See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)</a></p><p><b>status</b>: final</p><p><b>code</b>: Long-term - 30°C/65% RH - 18 months (X) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href=\"#Specimen_872a645f-120e-44c0-62c0-9be05acf543b\">See above (Specimen/872a645f-120e-44c0-62c0-9be05acf543b)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm30C-18m-2-Description\"> </a></li><li><a name=\"LongTerm30C-18m-2-Assay\"> </a></li><li><a name=\"LongTerm30C-18m-2-Impurity1\"> </a></li><li><a name=\"LongTerm30C-18m-2-Impurity2\"> </a></li><li><a name=\"LongTerm30C-18m-2-ImpurityUnspecified\"> </a></li><li><a name=\"LongTerm30C-18m-2-ImpurityTotal\"> </a></li><li><a name=\"LongTerm30C-18m-2-Identification\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm30C-18m-2-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-2-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-2-Impurity1\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-2-Impurity2\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.218 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-2-ImpurityUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.0518 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-2-ImpurityTotal\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.818 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-2-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-Description</b><a name=\"LongTerm30C-18m-2-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-Impurity1</b><a name=\"LongTerm30C-18m-2-Impurity1\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-Impurity2</b><a name=\"LongTerm30C-18m-2-Impurity2\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.218 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-ImpurityUnspecified</b><a name=\"LongTerm30C-18m-2-ImpurityUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.0518 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-ImpurityTotal</b><a name=\"LongTerm30C-18m-2-ImpurityTotal\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.818 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-Assay</b><a name=\"LongTerm30C-18m-2-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-Identification</b><a name=\"LongTerm30C-18m-2-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d\">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>" ] ; # fhir:contained ( [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-2-Description" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69" ] # ObservationDefinition\/Description ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DESC" ] ; fhir:display [ fhir:v "Description" ] ] ) ; fhir:text [ fhir:v "Description" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-2-Impurity1" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DGP" ] ; fhir:display [ fhir:v "Degradation Products" ] ] ) ; fhir:text [ fhir:v "Degradation Products" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.118"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity" ] # could have the code of an impurity substance, or could have an extension to point to it as a resource ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-2-Impurity2" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.218"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity 2" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-2-ImpurityUnspecified" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.0518"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<" ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Any Unspecified Impurity" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-2-ImpurityTotal" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.818"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Total Impurities" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-2-Assay" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119" ] # ObservationDefinition\/Assay ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] ) ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.118"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-2-Identification" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b" ] # ObservationDefinition\/Identification ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IDT" ] ; fhir:display [ fhir:v "Identification" ] ] ) ; fhir:text [ fhir:v "Identification" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] ) ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12" ] # ActivityDefinition\/activityLongTerm30X-18 ] ] ) ; # use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan # that would mean using sub-ActivityDefintions probably fhir:status [ fhir:v "final"] ; # fhir:code [ fhir:text [ fhir:v "Long-term - 30°C/65% RH - 18 months (X)" ] ] ; # fhir:subject [ fhir:reference [ fhir:v "Substance/cbcecab6-374c-396f-29be-877da7285e8d" ] # Substance\/actual-batch-substance-2 ] ; # fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime] ; # fhir:performer ( [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; # fhir:specimen [ fhir:reference [ fhir:v "Specimen/872a645f-120e-44c0-62c0-9be05acf543b" ] # Specimen\/stability18months-2 ] ; # fhir:hasMember ( [ fhir:reference [ fhir:v "#LongTerm30C-18m-2-Description" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-2-Assay" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-2-Impurity1" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-2-Impurity2" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-2-ImpurityUnspecified" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-2-ImpurityTotal" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-2-Identification" ] ] ) . # <urn:uuid:004ed877-7729-834e-3b6b-a2cf4bdb2377> a fhir:Observation ; fhir:id [ fhir:v "004ed877-7729-834e-3b6b-a2cf4bdb2377"] ; # LongTerm30C-18m-3 fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"004ed877-7729-834e-3b6b-a2cf4bdb2377\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "004ed877-7729-834e-3b6b-a2cf4bdb2377" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_c9b53a46-2f61-7b3f-5780-5f5c79a47f12\">See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)</a></p><p><b>status</b>: final</p><p><b>code</b>: Long-term - 30°C/65% RH - 18 months (X) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href=\"#Specimen_7c06a03c-9cf7-2e1b-a236-d60038f1439b\">See above (Specimen/7c06a03c-9cf7-2e1b-a236-d60038f1439b)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm30C-18m-3-Description\"> </a></li><li><a name=\"LongTerm30C-18m-3-Assay\"> </a></li><li><a name=\"LongTerm30C-18m-3-Impurity1\"> </a></li><li><a name=\"LongTerm30C-18m-3-Impurity2\"> </a></li><li><a name=\"LongTerm30C-18m-3-ImpurityUnspecified\"> </a></li><li><a name=\"LongTerm30C-18m-3-ImpurityTotal\"> </a></li><li><a name=\"LongTerm30C-18m-3-Identification\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm30C-18m-3-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-3-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-3-Impurity1\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-3-Impurity2\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.218 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-3-ImpurityUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.0518 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-3-ImpurityTotal\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.818 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm30C-18m-3-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-Description</b><a name=\"LongTerm30C-18m-3-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-Impurity1</b><a name=\"LongTerm30C-18m-3-Impurity1\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-Impurity2</b><a name=\"LongTerm30C-18m-3-Impurity2\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.218 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-ImpurityUnspecified</b><a name=\"LongTerm30C-18m-3-ImpurityUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.0518 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-ImpurityTotal</b><a name=\"LongTerm30C-18m-3-ImpurityTotal\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.818 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-Assay</b><a name=\"LongTerm30C-18m-3-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-Identification</b><a name=\"LongTerm30C-18m-3-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>" ] ; # fhir:contained ( [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-3-Description" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69" ] # ObservationDefinition\/Description ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DESC" ] ; fhir:display [ fhir:v "Description" ] ] ) ; fhir:text [ fhir:v "Description" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-3-Impurity1" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DGP" ] ; fhir:display [ fhir:v "Degradation Products" ] ] ) ; fhir:text [ fhir:v "Degradation Products" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.118"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity" ] # could have the code of an impurity substance, or could have an extension to point to it as a resource ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-3-Impurity2" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.218"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity 2" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-3-ImpurityUnspecified" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.0518"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<" ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Any Unspecified Impurity" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-3-ImpurityTotal" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.818"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Total Impurities" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-3-Assay" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119" ] # ObservationDefinition\/Assay ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] ) ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.118"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "LongTerm30C-18m-3-Identification" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b" ] # ObservationDefinition\/Identification ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IDT" ] ; fhir:display [ fhir:v "Identification" ] ] ) ; fhir:text [ fhir:v "Identification" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] ) ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12" ] # ActivityDefinition\/activityLongTerm30X-18 ] ] ) ; # use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan # that would mean using sub-ActivityDefintions probably fhir:status [ fhir:v "final"] ; # fhir:code [ fhir:text [ fhir:v "Long-term - 30°C/65% RH - 18 months (X)" ] ] ; # fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; # fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime] ; # fhir:performer ( [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; # fhir:specimen [ fhir:reference [ fhir:v "Specimen/7c06a03c-9cf7-2e1b-a236-d60038f1439b" ] # Specimen\/stability18months-3 ] ; # fhir:hasMember ( [ fhir:reference [ fhir:v "#LongTerm30C-18m-3-Description" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-3-Assay" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-3-Impurity1" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-3-Impurity2" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-3-ImpurityUnspecified" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-3-ImpurityTotal" ] ] [ fhir:reference [ fhir:v "#LongTerm30C-18m-3-Identification" ] ] ) . # <urn:uuid:b04c9321-069c-4da8-8ed0-86337ea22c30> a fhir:Specimen ; fhir:id [ fhir:v "b04c9321-069c-4da8-8ed0-86337ea22c30"] ; # acceleratedInitial-3m-1 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"b04c9321-069c-4da8-8ed0-86337ea22c30\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "b04c9321-069c-4da8-8ed0-86337ea22c30" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 40°C/75% RH</p></blockquote></div>" ] ; # fhir:collection [ fhir:collected [ fhir:v "2020-06"^^xsd:gYearMonth ] ] ; # fhir:processing ( [ fhir:description [ fhir:v "No storage" ] ] [ fhir:description [ fhir:v "40°C/75% RH" ] ] ) . # <urn:uuid:f958e1e9-6023-4e39-2ffe-a9c8f135a2dd> a fhir:Observation ; fhir:id [ fhir:v "f958e1e9-6023-4e39-2ffe-a9c8f135a2dd"] ; # Accelerated40C-3m fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"f958e1e9-6023-4e39-2ffe-a9c8f135a2dd\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "f958e1e9-6023-4e39-2ffe-a9c8f135a2dd" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9\">See above (ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9)</a></p><p><b>status</b>: final</p><p><b>code</b>: Accelerated - 40°C/67% RH - 3 months (X) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href=\"#Specimen_b04c9321-069c-4da8-8ed0-86337ea22c30\">See above (Specimen/b04c9321-069c-4da8-8ed0-86337ea22c30)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"Accelerated40C-3m-1-Description\"> </a></li><li><a name=\"Accelerated40C-3m-1-Assay\"> </a></li><li><a name=\"Accelerated40C-3m-1-Impurity1\"> </a></li><li><a name=\"Accelerated40C-3m-1-Impurity2\"> </a></li><li><a name=\"Accelerated40C-3m-1-ImpurityUnspecified\"> </a></li><li><a name=\"Accelerated40C-3m-1-ImpurityTotal\"> </a></li><li><a name=\"Accelerated40C-3m-1-Identification\"> </a></li></ul><blockquote><p/><p><a name=\"Accelerated40C-3m-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Doesn't comply <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3m-1-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.113 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3m-1-Impurity1\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.113 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3m-1-Impurity2\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.213 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3m-1-ImpurityUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.0513 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3m-1-ImpurityTotal\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.813 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3m-1-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-Description</b><a name=\"Accelerated40C-3m-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69\">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Doesn't comply <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-Impurity1</b><a name=\"Accelerated40C-3m-1-Impurity1\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.113 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-Impurity2</b><a name=\"Accelerated40C-3m-1-Impurity2\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.213 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-ImpurityUnspecified</b><a name=\"Accelerated40C-3m-1-ImpurityUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87\">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.0513 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-ImpurityTotal</b><a name=\"Accelerated40C-3m-1-ImpurityTotal\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.813 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-Assay</b><a name=\"Accelerated40C-3m-1-Assay\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119\">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.113 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-Identification</b><a name=\"Accelerated40C-3m-1-Identification\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b\">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd\">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>" ] ; # fhir:contained ( [ a fhir:Observation ; fhir:id [ fhir:v "Accelerated40C-3m-1-Description" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69" ] # ObservationDefinition\/Description ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DESC" ] ; fhir:display [ fhir:v "Description" ] ] ) ; fhir:text [ fhir:v "Description" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Doesn't comply" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "Accelerated40C-3m-1-Impurity1" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "DGP" ] ; fhir:display [ fhir:v "Degradation Products" ] ] ) ; fhir:text [ fhir:v "Degradation Products" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.113"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity" ] # could have the code of an impurity substance, or could have an extension to point to it as a resource ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "Accelerated40C-3m-1-Impurity2" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.213"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Impurity 2" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "Accelerated40C-3m-1-ImpurityUnspecified" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.0513"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<" ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Any Unspecified Impurity" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "Accelerated40C-3m-1-ImpurityTotal" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e" ] # ObservationDefinition\/Impurities ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] ) ; fhir:text [ fhir:v "Impurities" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.813"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ; ( fhir:component [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Total Impurities" ] ] ] ) ] [ a fhir:Observation ; fhir:id [ fhir:v "Accelerated40C-3m-1-Assay" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119" ] # ObservationDefinition\/Assay ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] ) ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "0.113"^^xsd:decimal ] ; fhir:unit [ fhir:v "% w/w" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] [ a fhir:Observation ; fhir:id [ fhir:v "Accelerated40C-3m-1-Identification" ] ; fhir:instantiates [ a fhir:Reference ; fhir:reference [ fhir:v "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b" ] # ObservationDefinition\/Identification ] ; fhir:status [ fhir:v "final" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IDT" ] ; fhir:display [ fhir:v "Identification" ] ] ) ; fhir:text [ fhir:v "Identification" ] ] ; fhir:subject [ fhir:reference [ fhir:v "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd" ] # Substance\/actual-batch-substance-3 ] ; fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; ( fhir:performer [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Complies" ] ] ] ) ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9" ] # ActivityDefinition\/activityAccelerated40X-3 ] ] ) ; # use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan # that would mean using sub-ActivityDefintions probably fhir:status [ fhir:v "final"] ; # fhir:code [ fhir:text [ fhir:v "Accelerated - 40°C/67% RH - 3 months (X)" ] ] ; # fhir:subject [ fhir:reference [ fhir:v "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87" ] # Substance\/actual-batch-substance ] ; # fhir:effective [ fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime] ; # fhir:performer ( [ fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08" ] # Organization\/378fbe5f-5926-3a5c-4c64-5428df877b08 ] ) ; # fhir:specimen [ fhir:reference [ fhir:v "Specimen/b04c9321-069c-4da8-8ed0-86337ea22c30" ] # Specimen\/acceleratedInitial-3m-1 ] ; # fhir:hasMember ( [ fhir:reference [ fhir:v "#Accelerated40C-3m-1-Description" ] ] [ fhir:reference [ fhir:v "#Accelerated40C-3m-1-Assay" ] ] [ fhir:reference [ fhir:v "#Accelerated40C-3m-1-Impurity1" ] ] [ fhir:reference [ fhir:v "#Accelerated40C-3m-1-Impurity2" ] ] [ fhir:reference [ fhir:v "#Accelerated40C-3m-1-ImpurityUnspecified" ] ] [ fhir:reference [ fhir:v "#Accelerated40C-3m-1-ImpurityTotal" ] ] [ fhir:reference [ fhir:v "#Accelerated40C-3m-1-Identification" ] ] ) . # <urn:uuid:62c1b1b4-8d15-26d2-57f9-25a2f60b6181> a fhir:Organization ; fhir:id [ fhir:v "62c1b1b4-8d15-26d2-57f9-25a2f60b6181"] ; # manufacturer fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"62c1b1b4-8d15-26d2-57f9-25a2f60b6181\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "62c1b1b4-8d15-26d2-57f9-25a2f60b6181" </p></div><p><b>identifier</b>: id: 3003040516</p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ; # FDA establishment identifier fhir:value [ fhir:v "3003040516" ] ] ) ; # fhir:name [ fhir:v "AAA Molybdenum Products, Inc."] ; # fhir:contact ( [ fhir:address [ ( fhir:line [ fhir:v "7233 W 116th Pl" ] [ fhir:v "Ste C" ] ) ; fhir:city [ fhir:v "Broomfield" ] ; fhir:state [ fhir:v "Colorado" ] ; fhir:postalCode [ fhir:v "80020" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . # <urn:uuid:6049d921-9935-90b7-4efc-894a66483c00> a fhir:Organization ; fhir:id [ fhir:v "6049d921-9935-90b7-4efc-894a66483c00"] ; # tester fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"6049d921-9935-90b7-4efc-894a66483c00\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "6049d921-9935-90b7-4efc-894a66483c00" </p></div><p><b>identifier</b>: id: 3007270600</p><p><b>name</b>: Advanced Analytical Testing Laboratories Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>30 Silverline Drive North Brunswick New Jersey 08902 USA </td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ; fhir:value [ fhir:v "3007270600" ] ] ) ; # could also use assigner here, for #74 fhir:name [ fhir:v "Advanced Analytical Testing Laboratories Inc."] ; # fhir:contact ( [ fhir:address [ ( fhir:line [ fhir:v "30 Silverline Drive" ] ) ; fhir:city [ fhir:v "North Brunswick" ] ; fhir:state [ fhir:v "New Jersey" ] ; fhir:postalCode [ fhir:v "08902" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . # <urn:uuid:2e3a85b5-790a-a108-3627-edf0ec6f1210> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "2e3a85b5-790a-a108-3627-edf0ec6f1210"] ; # substance1 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"2e3a85b5-790a-a108-3627-edf0ec6f1210\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition "2e3a85b5-790a-a108-3627-edf0ec6f1210" </p></div><p><b>identifier</b>: id: 4444455555</p><p><b>manufacturer</b>: <a href=\"#Organization_62c1b1b4-8d15-26d2-57f9-25a2f60b6181\">See above (Organization/62c1b1b4-8d15-26d2-57f9-25a2f60b6181)</a></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://example.company.org/companySubstanceIdentifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "4444455555" ] ] ) ; # fhir:manufacturer ( [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productSiteUtilizationType-local-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Release stability" ] ; fhir:display [ fhir:v "Release stability" ] ] ] ) ; fhir:reference [ fhir:v "Organization/62c1b1b4-8d15-26d2-57f9-25a2f60b6181" ] # Organization\/manufacturer ] ) ; # fhir:name ( [ fhir:name [ fhir:v "Stelbatolol" ] ] ) . # <urn:uuid:e2359a4e-3091-23f8-2242-87e701830d55> a fhir:Organization ; fhir:id [ fhir:v "e2359a4e-3091-23f8-2242-87e701830d55"] ; # substance-manufacturer fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"e2359a4e-3091-23f8-2242-87e701830d55\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "e2359a4e-3091-23f8-2242-87e701830d55" </p></div><p><b>identifier</b>: id: 3003040516</p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ; # FDA establishment identifier fhir:value [ fhir:v "3003040516" ] ] ) ; # fhir:name [ fhir:v "AAA Molybdenum Products, Inc."] ; # fhir:contact ( [ fhir:address [ ( fhir:line [ fhir:v "7233 W 116th Pl" ] [ fhir:v "Ste C" ] ) ; fhir:city [ fhir:v "Broomfield" ] ; fhir:state [ fhir:v "Colorado" ] ; fhir:postalCode [ fhir:v "80020" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . # <urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08> a fhir:Organization ; fhir:id [ fhir:v "378fbe5f-5926-3a5c-4c64-5428df877b08"] ; # testing lab, 378fbe5f-5926-3a5c-4c64-5428df877b08 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"378fbe5f-5926-3a5c-4c64-5428df877b08\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08" </p></div><p><b>name</b>: Testing Lab</p></div>" ] ; # fhir:name [ fhir:v "Testing Lab"] . # <urn:uuid:a3fdc23b-6c16-2e65-481e-3fc895b37b87> a fhir:Substance ; fhir:id [ fhir:v "a3fdc23b-6c16-2e65-481e-3fc895b37b87"] ; # actual-batch-substance fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"a3fdc23b-6c16-2e65-481e-3fc895b37b87\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "a3fdc23b-6c16-2e65-481e-3fc895b37b87" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-01</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_e2359a4e-3091-23f8-2242-87e701830d55\">See above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)</a></p><blockquote><p><b>url</b></p><code>container</code></blockquote></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id: CAT1</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_2e3a85b5-790a-a108-3627-edf0ec6f1210\">See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)</a></td></tr></table></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"^^xsd:anyURI ] ; ( fhir:extension [ fhir:url [ fhir:v "manufacturingDate"^^xsd:anyURI ] ; fhir:value [ fhir:v "2020-01"^^xsd:gYearMonth ] ] [ fhir:url [ fhir:v "batchQuantity"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "120"^^xsd:decimal ] ; fhir:unit [ fhir:v "kg" ] ] ] [ fhir:url [ fhir:v "batchUtilization"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C133990" ] ; fhir:display [ fhir:v "Commercial" ] ] ) ; # could also be C185328 Stability Study? fhir:text [ fhir:v "Production" ] ] ] [ fhir:url [ fhir:v "assignedManufacturer"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "Organization/e2359a4e-3091-23f8-2242-87e701830d55" ] # Organization\/substance-manufacturer ] ] [ fhir:url [ fhir:v "container"^^xsd:anyURI ] ; ( fhir:extension [ fhir:url [ fhir:v "type"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "packaged in LDPE bags within HDPE drums" ] ] ] ) ] ) ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "2019-09-08"^^xsd:date ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "2022-09-08"^^xsd:date ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "4.8"^^xsd:decimal ] ; fhir:unit [ fhir:v "kg" ] ] ] ) ; # fhir:identifier ( [ fhir:value [ fhir:v "CAT1" ] ] ) ; # fhir:instance [ fhir:v "true"^^xsd:boolean] ; # fhir:code [ fhir:reference [ fhir:reference [ fhir:v "SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210" ] # SubstanceDefinition\/substance1 ] ] . # <urn:uuid:cbcecab6-374c-396f-29be-877da7285e8d> a fhir:Substance ; fhir:id [ fhir:v "cbcecab6-374c-396f-29be-877da7285e8d"] ; # actual-batch-substance-2 fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"cbcecab6-374c-396f-29be-877da7285e8d\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "cbcecab6-374c-396f-29be-877da7285e8d" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-02</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_e2359a4e-3091-23f8-2242-87e701830d55\">See above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id: CAT2</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_2e3a85b5-790a-a108-3627-edf0ec6f1210\">See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)</a></td></tr></table></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"^^xsd:anyURI ] ; ( fhir:extension [ fhir:url [ fhir:v "manufacturingDate"^^xsd:anyURI ] ; fhir:value [ fhir:v "2020-02"^^xsd:gYearMonth ] ] [ fhir:url [ fhir:v "batchQuantity"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "120"^^xsd:decimal ] ; fhir:unit [ fhir:v "kg" ] ] ] [ fhir:url [ fhir:v "batchUtilization"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C133990" ] ; fhir:display [ fhir:v "Commercial" ] ] ) ; # could also be C185328 Stability Study? fhir:text [ fhir:v "Production" ] ] ] [ fhir:url [ fhir:v "assignedManufacturer"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "Organization/e2359a4e-3091-23f8-2242-87e701830d55" ] # Organization\/substance-manufacturer ] ] ) ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "2019-09-08"^^xsd:date ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "2022-09-08"^^xsd:date ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "4.8"^^xsd:decimal ] ; fhir:unit [ fhir:v "kg" ] ] ] ) ; # fhir:identifier ( [ fhir:value [ fhir:v "CAT2" ] ] ) ; # fhir:instance [ fhir:v "true"^^xsd:boolean] ; # fhir:code [ fhir:reference [ fhir:reference [ fhir:v "SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210" ] # SubstanceDefinition\/substance1 ] ] . # <urn:uuid:ae1f3b4c-4f14-1460-6903-7260959ea2cd> a fhir:Substance ; fhir:id [ fhir:v "ae1f3b4c-4f14-1460-6903-7260959ea2cd"] ; # actual-batch-substance-3 fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"ae1f3b4c-4f14-1460-6903-7260959ea2cd\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "ae1f3b4c-4f14-1460-6903-7260959ea2cd" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-03</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_e2359a4e-3091-23f8-2242-87e701830d55\">See above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id: CAT3</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_2e3a85b5-790a-a108-3627-edf0ec6f1210\">See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)</a></td></tr></table></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"^^xsd:anyURI ] ; ( fhir:extension [ fhir:url [ fhir:v "manufacturingDate"^^xsd:anyURI ] ; fhir:value [ fhir:v "2020-03"^^xsd:gYearMonth ] ] [ fhir:url [ fhir:v "batchQuantity"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "120"^^xsd:decimal ] ; fhir:unit [ fhir:v "kg" ] ] ] [ fhir:url [ fhir:v "batchUtilization"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C133990" ] ; fhir:display [ fhir:v "Commercial" ] ] ) ; # could also be C185328 Stability Study? fhir:text [ fhir:v "Production" ] ] ] [ fhir:url [ fhir:v "assignedManufacturer"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "Organization/e2359a4e-3091-23f8-2242-87e701830d55" ] # Organization\/substance-manufacturer ] ] ) ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "2019-09-08"^^xsd:date ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "2022-09-08"^^xsd:date ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "4.8"^^xsd:decimal ] ; fhir:unit [ fhir:v "kg" ] ] ] ) ; # fhir:identifier ( [ fhir:value [ fhir:v "CAT3" ] ] ) ; # fhir:instance [ fhir:v "true"^^xsd:boolean] ; # fhir:code [ fhir:reference [ fhir:reference [ fhir:v "SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210" ] # SubstanceDefinition\/substance1 ] ] . #
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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