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
// Substance Stability Study
{
"resourceType" : "Bundle",
"id" : "bundle-drug-stability-pq-ex2-sub",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq"
]
},
"type" : "collection",
"entry" : [
// Section 11 - Stability Study - Results
{
"fullUrl" : "urn:uuid:54c8e8dc-9a19-0dc2-910e-d5a05d6ba003",
"resource" : {
"resourceType" : "DiagnosticReport",
"id" : "studyResultsReport",
"text" : {
"status" : "extensions",
"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:\u00a0PLO555</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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b"
}
},
// PlanDefinition/stabilityStudyProtocol
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq",
"valueCodeableConcept" : {
"text" : "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
have no place to put a context. Ideally this would be a code/code pair.
Code says "statistical model", code (or text) then says what it is
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-containerOrientation-local-pq",
"code" : "horizontal",
"display" : "horizontal"
}
],
"text" : "Horizontal"
}
}
],
"identifier" : [
{
"system" : "https://eudract.europa.eu/example/identifier",
"value" : "PLO555"
}
],
"status" : "final",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq",
"code" : "Stability Study Report",
"display" : "Stability Study Report"
}
]
},
"effectiveDateTime" : "2019-09-08",
"_effectiveDateTime" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-timePointDescription-local-pq",
"code" : "Delayed Start Code",
"display" : "Delayed Start Code"
}
],
"text" : "Refrigerated delayed testing"
}
}
]
},
"performer" : [
{
"reference" : "Organization/6049d921-9935-90b7-4efc-894a66483c00"
}
],
"result" : [
// Organization/tester
{
"reference" : "Observation/588a6787-0454-55ef-0b8a-4c8941b6976c"
},
// Observation/LongTerm30C-initial-1
{
"reference" : "Observation/930c7f69-2546-7148-2069-b3be3a755edf"
},
// Observation/LongTerm30C-Initial-2
{
"reference" : "Observation/8070745c-30c4-a52e-41fd-600a913578d4"
},
// Observation/LongTerm30C-Initial-3
{
"reference" : "Observation/f16113fe-27e7-0aa2-6787-9415f5051900"
},
// Observation/LongTerm30C-18m
{
"reference" : "Observation/1b25eb25-9149-02f6-9676-c87f90c64904"
},
// Observation/LongTerm30C-18m-2
{
"reference" : "Observation/004ed877-7729-834e-3b6b-a2cf4bdb2377"
},
// Observation/LongTerm30C-18m-3
{
"reference" : "Observation/f958e1e9-6023-4e39-2ffe-a9c8f135a2dd"
}
],
"conclusion" : "The samples have been assessed and the conclusion is..."
}
},
// Observation/Accelerated40C-3m
{
"fullUrl" : "urn:uuid:c3973835-10ca-0796-0a26-aa8afafc9c5b",
"resource" : // Section 11 - Stability Study - Protocol
{
"resourceType" : "PlanDefinition",
"id" : "c3973835-10ca-0796-0a26-aa8afafc9c5b",
"text" : // stabilityStudyProtocol
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b",
"title" : "Stability Monitoring Program",
"type" : // http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b
// Added type (8/22/2023)
{
"coding" : [
{
"system" : "http://example.org/fhir/code/planType",
"code" : "1244588",
"display" : "Stability Study Protocol"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210"
},
"description" : "Description of the study study plan which includes tests, time points, storage conditions, method",
"action" : [
// SubstanceDefinition/substance1
// 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
// end of accelerated
{
"title" : "Stability Test Protocol for Long-term and Accelerated Storage of Stelbatolol",
"action" : [
{
"title" : "Long-Term",
"description" : "30°C/65% RH",
"action" : [
// TODO add codes here for the different levels?
{
"title" : "Initial",
"timingTiming" : // 0 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 0,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 0,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "XY",
"definitionCanonical" : "ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"
}
]
},
// the categories to do at this step
// Long term
// ActivityDefinition/activityLongTerm30XY-Initial
{
"title" : "3",
"timingTiming" : // 3 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 3,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 3,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e"
}
]
},
// ActivityDefinition/activityLongTerm30X-3
{
"title" : "6",
"timingTiming" : // 6 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 6,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 6,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3"
}
]
},
// ActivityDefinition/activityLongTerm30X-6
{
"title" : "9",
"timingTiming" : // 9 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 9,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 9,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201"
}
]
},
// ActivityDefinition/activityLongTerm30X-9
{
"title" : "12",
"timingTiming" : // 12 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 12,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 12,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"
}
]
},
// ActivityDefinition/activityLongTerm30X-12
{
"title" : "18",
"timingTiming" : // 18 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 18,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 18,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"
}
]
},
// ActivityDefinition/activityLongTerm30X-18
{
"title" : "24",
"timingTiming" : // 24 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 24,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 24,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"
}
]
},
// ActivityDefinition/activityLongTerm30X-24
{
"title" : "36",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 36,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 36,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "(X)",
"requiredBehavior" : "could",
"definitionCanonical" : "ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149"
}
]
}
]
},
// ActivityDefinition/activityLongTerm30X-36
// 36 months
{
"title" : "Accelerated",
"description" : "40°C/75% RH",
"action" : [
{
"title" : "Initial",
"timingTiming" : // 0 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 0,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 0,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "XY",
"definitionCanonical" : "ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495"
}
]
},
// second category at this step
// ActivityDefinition/activityAccelerated40XY-Initial
{
"title" : "3",
"timingTiming" : // 3 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 3,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 3,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"
}
]
},
// ActivityDefinition/activityAccelerated40X-3
{
"title" : "6",
"timingTiming" : // 6 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 6,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 6,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817"
}
]
},
// ActivityDefinition/activityAccelerated40X-6
{
"title" : "9",
"timingTiming" : // 9 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 9,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 9,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "-"
}
]
},
// none
{
"title" : "12",
"timingTiming" : // 12 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 12,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 12,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "-"
}
]
},
// none
{
"title" : "18",
"timingTiming" : // 18 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 18,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 18,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "-"
}
]
},
// none
{
"title" : "24",
"timingTiming" : // 24 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 24,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 24,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "-"
}
]
},
// none
{
"title" : "36",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 36,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 36,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "-"
}
]
}
]
}
]
}
]
}
},
// 36 months
// end of long term
{
"fullUrl" : "urn:uuid:643d8b44-71f4-2b58-07e8-51c22b294b25",
"resource" : {
"resourceType" : "SpecimenDefinition",
"id" : "643d8b44-71f4-2b58-07e8-51c22b294b25",
"text" : // specimenDefStoredAt30
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25",
"status" : "active",
"typeTested" : [
// <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
{
"preference" : "preferred",
"handling" : [
// easier than temp range? which doesnt have humidity
{
"instruction" : "30°C/65% RH"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:10d7b693-7a0e-2f71-9a10-642e5a0a5d42",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "10d7b693-7a0e-2f71-9a10-642e5a0a5d42",
"text" : // activityLongTerm30XY-Initial
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42",
"title" : "Long-term - 30°C/65% RH - XY",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba",
"http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42
// ObservationDefinition/longTerm30X
// ObservationDefinition/longTerm30Y
{
"fullUrl" : "urn:uuid:480a61f8-14b3-233e-8e5f-7f0db9696a1e",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "480a61f8-14b3-233e-8e5f-7f0db9696a1e",
"text" : // activityLongTerm30X-3
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e",
"title" : "Long-term - 30°C/65% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e
// ObservationDefinition/longTerm30X
{
"fullUrl" : "urn:uuid:bee486c4-6ab5-6293-4114-d4be24f303d3",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "bee486c4-6ab5-6293-4114-d4be24f303d3",
"text" : // activityLongTerm30X-6
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3",
"title" : "Long-term - 30°C/65% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3
// ObservationDefinition/longTerm30X
{
"fullUrl" : "urn:uuid:99893d3c-520c-8d7b-6d73-f46b1a662201",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "99893d3c-520c-8d7b-6d73-f46b1a662201",
"text" : // activityLongTerm30X-9
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201",
"title" : "Long-term - 30°C/65% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201
// ObservationDefinition/longTerm30X
{
"fullUrl" : "urn:uuid:b3254b8e-6fc3-88d3-7d38-0afcf13c4f67",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "b3254b8e-6fc3-88d3-7d38-0afcf13c4f67",
"text" : // activityLongTerm30X-12
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67",
"title" : "Long-term - 30°C/65% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67
// ObservationDefinition/longTerm30X
{
"fullUrl" : "urn:uuid:c9b53a46-2f61-7b3f-5780-5f5c79a47f12",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "c9b53a46-2f61-7b3f-5780-5f5c79a47f12",
"text" : // activityLongTerm30X-18
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12",
"title" : "Long-term - 30°C/65% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12
// ObservationDefinition/longTerm30X
{
"fullUrl" : "urn:uuid:d6f7de9d-57a5-6a2c-1c2f-0d65718860f2",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "d6f7de9d-57a5-6a2c-1c2f-0d65718860f2",
"text" : // activityLongTerm30X-24
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2",
"title" : "Long-term - 30°C/65% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2
// ObservationDefinition/longTerm30X
{
"fullUrl" : "urn:uuid:75073965-82eb-407d-34cf-3a7767a38149",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "75073965-82eb-407d-34cf-3a7767a38149",
"text" : // activityLongTerm30X-36
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149",
"title" : "Long-term - 30°C/65% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149
// ObservationDefinition/longTerm30X
{
"fullUrl" : "urn:uuid:18762cff-9e29-6e71-1184-e9202fee8cba",
"resource" : // can have others
{
"resourceType" : "ObservationDefinition",
"id" : "18762cff-9e29-6e71-1184-e9202fee8cba",
"text" : // longTerm30X
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba",
"title" : "X",
"status" : "active",
"code" : // <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
{
"text" : "Battery of tests 'X' at 30°C/65% RH"
},
"specimen" : [
{
"reference" : "SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25"
}
],
"hasMember" : [
// SpecimenDefinition/specimenDefStoredAt30
{
"reference" : "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"
},
// ObservationDefinition/Description
{
"reference" : "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"
},
// ObservationDefinition/Assay
{
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
}
]
}
},
// ObservationDefinition/Impurities
{
"fullUrl" : "urn:uuid:559ffdc3-349b-a4a3-a651-ce2715f08d69",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "559ffdc3-349b-a4a3-a651-ce2715f08d69",
"text" : // Description
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69",
"title" : "Description",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "A white to brown powder"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:7943795a-2abe-666f-545f-133e23b97119",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "7943795a-2abe-666f-545f-133e23b97119",
"text" : // Assay
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119",
"title" : "Assay (% w/w) (Mean)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay (% w/w) (Mean)"
},
"qualifiedValue" : [
{
"range" : {
"low" : {
"value" : 98,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"high" : {
"value" : 102,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:73d9d304-a0b8-31b6-1165-346563b9305e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "73d9d304-a0b8-31b6-1165-346563b9305e",
"text" : // Impurities
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e",
"title" : "Drug-related Impurities Content by LC (% w/w)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
]
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Impurity"
}
],
"range" : // could be a code
{
"high" : {
"value" : 0.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 2"
}
],
"range" : {
"high" : {
"value" : 0.52,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Any Unspecified Impurity"
}
],
"range" : {
"high" : {
"value" : 0.10,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Total Impurities"
}
],
"range" : {
"high" : {
"value" : 2.0,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what impurity this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:31abea79-81da-17f8-9d8c-94e9bb75876e",
"resource" : // can have others
{
"resourceType" : "ObservationDefinition",
"id" : "31abea79-81da-17f8-9d8c-94e9bb75876e",
"text" : // longTerm30Y
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e",
"title" : "Y",
"status" : "active",
"code" : // <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
{
"text" : "Battery of tests 'Y' at 30°C/65% RH"
},
"specimen" : [
{
"reference" : "SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25"
}
],
"hasMember" : [
// SpecimenDefinition/specimenDefStoredAt30
{
"reference" : "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"
}
]
}
},
// ObservationDefinition/Identification
{
"fullUrl" : "urn:uuid:6b96124b-1a44-0b6b-6783-d6c49360230b",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "6b96124b-1a44-0b6b-6783-d6c49360230b",
"text" : // Identification
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b",
"title" : "Identification",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Complies"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:306637ec-1041-80e8-8e77-e7ca814253e1",
"resource" : {
"resourceType" : "SpecimenDefinition",
"id" : "306637ec-1041-80e8-8e77-e7ca814253e1",
"text" : // specimenDefStoredAt40
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1",
"status" : "active",
"typeTested" : [
// <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
{
"preference" : "preferred",
"handling" : [
{
"instruction" : "40°C/75% RH"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:1b43a536-3c29-3427-0b93-e35866ef8495",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "1b43a536-3c29-3427-0b93-e35866ef8495",
"text" : // activityAccelerated40XY-Initial
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495",
"title" : "Accelerated - 40°C/70% RH - XY",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc",
"http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495
// ObservationDefinition/accelerated40X
// ObservationDefinition/accelerated40Y
{
"fullUrl" : "urn:uuid:8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9",
"text" : // activityAccelerated40X-3
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9",
"title" : "Accelerated - 40°C/70% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9
// ObservationDefinition/accelerated40X
{
"fullUrl" : "urn:uuid:cf2f00df-971f-0bab-8768-4251b1ad0817",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "cf2f00df-971f-0bab-8768-4251b1ad0817",
"text" : // activityAccelerated40X-6
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817",
"title" : "Accelerated - 40°C/70% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817
// ObservationDefinition/accelerated40X
{
"fullUrl" : "urn:uuid:35fa7b97-98d3-35d3-5672-4ab1047d57fc",
"resource" : // can have others
{
"resourceType" : "ObservationDefinition",
"id" : "35fa7b97-98d3-35d3-5672-4ab1047d57fc",
"text" : // accelerated40X
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc",
"title" : "X",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc
{
"text" : "Battery of tests 'X' at 40°C/75% RH"
},
"specimen" : [
{
"reference" : "SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1"
}
],
"hasMember" : [
// SpecimenDefinition/specimenDefStoredAt40
{
"reference" : "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"
},
// ObservationDefinition/Description
{
"reference" : "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"
}
]
}
},
// ObservationDefinition/Assay
{
"fullUrl" : "urn:uuid:accb8802-4223-61e2-8c79-2282e22a2bb6",
"resource" : // can have others
{
"resourceType" : "ObservationDefinition",
"id" : "accb8802-4223-61e2-8c79-2282e22a2bb6",
"text" : // accelerated40Y
{
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6",
"title" : "Y",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6
{
"text" : "Battery of tests 'Y' at 40°C/75% RH"
},
"specimen" : [
{
"reference" : "SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1"
}
],
"hasMember" : [
// SpecimenDefinition/specimenDefStoredAt40
{
"reference" : "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"
}
]
}
},
// ObservationDefinition/Identification
{
"fullUrl" : "urn:uuid:6a5354bf-602c-99f1-324b-0bb5f7e06cd5",
"resource" : {
"resourceType" : "Specimen",
"id" : "6a5354bf-602c-99f1-324b-0bb5f7e06cd5",
"text" : // stabilityInitial-1
{
"status" : "generated",
"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>"
},
"collection" : // when sample first taken, before the timed periods start
{
"collectedDateTime" : "2020-06"
},
"processing" : [
{
"description" : "No storage"
},
{
"description" : "25°C/60% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:588a6787-0454-55ef-0b8a-4c8941b6976c",
"resource" : {
"resourceType" : "Observation",
"id" : "588a6787-0454-55ef-0b8a-4c8941b6976c",
"text" : // LongTerm30C-initial-1
{
"status" : "extensions",
"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>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-1-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-1-Impurity1",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-1-Impurity2",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-1-ImpurityUnspecified",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.05,
"comparator" : "<",
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any Unspecified Impurity"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-1-ImpurityTotal",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.8,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total Impurities"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-1-Assay",
"instantiatesReference" : {
"reference" : "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
]
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.15,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-1-Identification",
"instantiatesReference" : {
"reference" : "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
}
],
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityLongTerm30XY-Initial
{
"text" : "Test Components - Long-term 25C etc - Initial (XYZ)"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"specimen" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"reference" : "Specimen/6a5354bf-602c-99f1-324b-0bb5f7e06cd5"
},
"hasMember" : [
// Specimen/stabilityInitial-1
{
"reference" : "#LongTerm30C-initial-1-Description"
},
{
"reference" : "#LongTerm30C-initial-1-Assay"
},
{
"reference" : "#LongTerm30C-initial-1-Impurity1"
},
{
"reference" : "#LongTerm30C-initial-1-Impurity2"
},
{
"reference" : "#LongTerm30C-initial-1-ImpurityUnspecified"
},
{
"reference" : "#LongTerm30C-initial-1-ImpurityTotal"
},
{
"reference" : "#LongTerm30C-initial-1-Identification"
}
]
}
},
{
"fullUrl" : "urn:uuid:3b550915-4467-83d3-340f-9bd6d2857191",
"resource" : {
"resourceType" : "Specimen",
"id" : "3b550915-4467-83d3-340f-9bd6d2857191",
"text" : // stabilityInitial-2
{
"status" : "generated",
"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>"
},
"collection" : // when sample first taken, before the timed periods start
{
"collectedDateTime" : "2020-06"
},
"processing" : [
{
"description" : "No storage"
},
{
"description" : "25°C/60% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:930c7f69-2546-7148-2069-b3be3a755edf",
"resource" : {
"resourceType" : "Observation",
"id" : "930c7f69-2546-7148-2069-b3be3a755edf",
"text" : // LongTerm30C-Initial-2
{
"status" : "extensions",
"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>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-2-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-2-Degradation-imp1",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.12,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-2-Degradation-imp2",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.22,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-2-Degradation-impUnspecified",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.052,
"comparator" : "<",
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any Unspecified Impurity"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-2-Degradation-impTotal",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.82,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total Impurities"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-2-Assay",
"instantiatesReference" : {
"reference" : "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
]
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.152,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-2-Identification",
"instantiatesReference" : {
"reference" : "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Does not comply"
}
}
],
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityLongTerm30XY-Initial
{
"text" : "Test Components - Long-term 25C etc - Initial (XYZ)"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"specimen" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"reference" : "Specimen/3b550915-4467-83d3-340f-9bd6d2857191"
},
"hasMember" : [
// Specimen/stabilityInitial-2
{
"reference" : "#LongTerm30C-initial-2-Description"
},
{
"reference" : "#LongTerm30C-initial-2-Assay"
},
{
"reference" : "#LongTerm30C-initial-2-Degradation-imp1"
},
{
"reference" : "#LongTerm30C-initial-2-Degradation-imp2"
},
{
"reference" : "#LongTerm30C-initial-2-Degradation-impUnspecified"
},
{
"reference" : "#LongTerm30C-initial-2-Degradation-impTotal"
},
{
"reference" : "#LongTerm30C-initial-2-Identification"
}
]
}
},
{
"fullUrl" : "urn:uuid:b1726ce3-8bb5-403e-2e9b-f5d79cc716f9",
"resource" : {
"resourceType" : "Specimen",
"id" : "b1726ce3-8bb5-403e-2e9b-f5d79cc716f9",
"text" : // stabilityInitial-3
{
"status" : "generated",
"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>"
},
"collection" : // when sample first taken, before the timed periods start
{
"collectedDateTime" : "2020-06"
},
"processing" : [
{
"description" : "No storage"
},
{
"description" : "25°C/60% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:8070745c-30c4-a52e-41fd-600a913578d4",
"resource" : {
"resourceType" : "Observation",
"id" : "8070745c-30c4-a52e-41fd-600a913578d4",
"text" : // LongTerm30C-Initial-3
{
"status" : "extensions",
"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>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-3-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-3-Degradation-imp1",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.12,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-3-Degradation-imp2",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.22,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-3-Degradation-impUnspecified",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.052,
"comparator" : "<",
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any Unspecified Impurity"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-3-Degradation-impTotal",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.82,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total Impurities"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-3-Assay",
"instantiatesReference" : {
"reference" : "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
]
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.152,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-initial-3-Identification",
"instantiatesReference" : {
"reference" : "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Does not comply"
}
}
],
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityLongTerm30XY-Initial
{
"text" : "Test Components - Long-term 25C etc - Initial (XYZ)"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"specimen" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"reference" : "Specimen/b1726ce3-8bb5-403e-2e9b-f5d79cc716f9"
},
"hasMember" : [
// Specimen/stabilityInitial-3
{
"reference" : "#LongTerm30C-initial-3-Description"
},
{
"reference" : "#LongTerm30C-initial-3-Assay"
},
{
"reference" : "#LongTerm30C-initial-3-Degradation-imp1"
},
{
"reference" : "#LongTerm30C-initial-3-Degradation-imp2"
},
{
"reference" : "#LongTerm30C-initial-3-Degradation-impUnspecified"
},
{
"reference" : "#LongTerm30C-initial-3-Degradation-impTotal"
},
{
"reference" : "#LongTerm30C-initial-3-Identification"
}
]
}
},
{
"fullUrl" : "urn:uuid:7aa5fdea-17d7-29f1-1ed4-5c05eb62285a",
"resource" : {
"resourceType" : "Specimen",
"id" : "7aa5fdea-17d7-29f1-1ed4-5c05eb62285a",
"text" : // stability18months-1
{
"status" : "generated",
"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>"
},
"collection" : {
"collectedDateTime" : "2020-06"
},
"processing" : [
{
"description" : "Store for 18 months",
"timePeriod" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq",
"valueDuration" : {
"value" : 18,
"unit" : "month"
}
}
],
"start" : "2020-12",
"end" : "2022-06"
}
},
{
"description" : "30°C/65% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:872a645f-120e-44c0-62c0-9be05acf543b",
"resource" : {
"resourceType" : "Specimen",
"id" : "872a645f-120e-44c0-62c0-9be05acf543b",
"text" : // stability18months-2
{
"status" : "generated",
"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>"
},
"collection" : {
"collectedDateTime" : "2020-06"
},
"processing" : [
{
"description" : "Store for 18 months",
"timePeriod" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq",
"valueDuration" : {
"value" : 18,
"unit" : "month"
}
}
],
"start" : "2020-12",
"end" : "2022-06"
}
},
{
"description" : "30°C/65% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:7c06a03c-9cf7-2e1b-a236-d60038f1439b",
"resource" : {
"resourceType" : "Specimen",
"id" : "7c06a03c-9cf7-2e1b-a236-d60038f1439b",
"text" : // stability18months-3
{
"status" : "generated",
"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>"
},
"collection" : {
"collectedDateTime" : "2020-06"
},
"processing" : [
{
"description" : "Store for 18 months",
"timePeriod" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq",
"valueDuration" : {
"value" : 18,
"unit" : "month"
}
}
],
"start" : "2020-12",
"end" : "2022-06"
}
},
{
"description" : "30°C/65% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:f16113fe-27e7-0aa2-6787-9415f5051900",
"resource" : {
"resourceType" : "Observation",
"id" : "f16113fe-27e7-0aa2-6787-9415f5051900",
"text" : // LongTerm30C-18m
{
"status" : "extensions",
"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>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-1-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-1-Impurity1",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.118,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-1-Impurity2",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.218,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-1-ImpurityUnspecified",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.0518,
"comparator" : "<",
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any Unspecified Impurity"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-1-ImpurityTotal",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.818,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total Impurities"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-1-Assay",
"instantiatesReference" : {
"reference" : "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
]
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.118,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-1-Identification",
"instantiatesReference" : {
"reference" : "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
}
],
"extension" : [
// 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
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityLongTerm30X-18
{
"text" : "Long-term - 30°C/65% RH - 18 months (X)"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"specimen" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"reference" : "Specimen/7aa5fdea-17d7-29f1-1ed4-5c05eb62285a"
},
"hasMember" : [
// Specimen/stability18months-1
{
"reference" : "#LongTerm30C-18m-1-Description"
},
{
"reference" : "#LongTerm30C-18m-1-Assay"
},
{
"reference" : "#LongTerm30C-18m-1-Impurity1"
},
{
"reference" : "#LongTerm30C-18m-1-Impurity2"
},
{
"reference" : "#LongTerm30C-18m-1-ImpurityUnspecified"
},
{
"reference" : "#LongTerm30C-18m-1-ImpurityTotal"
},
{
"reference" : "#LongTerm30C-18m-1-Identification"
}
]
}
},
{
"fullUrl" : "urn:uuid:1b25eb25-9149-02f6-9676-c87f90c64904",
"resource" : {
"resourceType" : "Observation",
"id" : "1b25eb25-9149-02f6-9676-c87f90c64904",
"text" : // LongTerm30C-18m-2
{
"status" : "extensions",
"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>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-2-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-2-Impurity1",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.118,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-2-Impurity2",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.218,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-2-ImpurityUnspecified",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.0518,
"comparator" : "<",
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any Unspecified Impurity"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-2-ImpurityTotal",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.818,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total Impurities"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-2-Assay",
"instantiatesReference" : {
"reference" : "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
]
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.118,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-2-Identification",
"instantiatesReference" : {
"reference" : "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
}
],
"extension" : [
// 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
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityLongTerm30X-18
{
"text" : "Long-term - 30°C/65% RH - 18 months (X)"
},
"subject" : {
"reference" : "Substance/cbcecab6-374c-396f-29be-877da7285e8d"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"specimen" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"reference" : "Specimen/872a645f-120e-44c0-62c0-9be05acf543b"
},
"hasMember" : [
// Specimen/stability18months-2
{
"reference" : "#LongTerm30C-18m-2-Description"
},
{
"reference" : "#LongTerm30C-18m-2-Assay"
},
{
"reference" : "#LongTerm30C-18m-2-Impurity1"
},
{
"reference" : "#LongTerm30C-18m-2-Impurity2"
},
{
"reference" : "#LongTerm30C-18m-2-ImpurityUnspecified"
},
{
"reference" : "#LongTerm30C-18m-2-ImpurityTotal"
},
{
"reference" : "#LongTerm30C-18m-2-Identification"
}
]
}
},
{
"fullUrl" : "urn:uuid:004ed877-7729-834e-3b6b-a2cf4bdb2377",
"resource" : {
"resourceType" : "Observation",
"id" : "004ed877-7729-834e-3b6b-a2cf4bdb2377",
"text" : // LongTerm30C-18m-3
{
"status" : "extensions",
"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>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-3-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-3-Impurity1",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.118,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-3-Impurity2",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.218,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-3-ImpurityUnspecified",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.0518,
"comparator" : "<",
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any Unspecified Impurity"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-3-ImpurityTotal",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.818,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total Impurities"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-3-Assay",
"instantiatesReference" : {
"reference" : "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
]
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.118,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm30C-18m-3-Identification",
"instantiatesReference" : {
"reference" : "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
}
],
"extension" : [
// 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
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityLongTerm30X-18
{
"text" : "Long-term - 30°C/65% RH - 18 months (X)"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"specimen" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"reference" : "Specimen/7c06a03c-9cf7-2e1b-a236-d60038f1439b"
},
"hasMember" : [
// Specimen/stability18months-3
{
"reference" : "#LongTerm30C-18m-3-Description"
},
{
"reference" : "#LongTerm30C-18m-3-Assay"
},
{
"reference" : "#LongTerm30C-18m-3-Impurity1"
},
{
"reference" : "#LongTerm30C-18m-3-Impurity2"
},
{
"reference" : "#LongTerm30C-18m-3-ImpurityUnspecified"
},
{
"reference" : "#LongTerm30C-18m-3-ImpurityTotal"
},
{
"reference" : "#LongTerm30C-18m-3-Identification"
}
]
}
},
{
"fullUrl" : "urn:uuid:b04c9321-069c-4da8-8ed0-86337ea22c30",
"resource" : {
"resourceType" : "Specimen",
"id" : "b04c9321-069c-4da8-8ed0-86337ea22c30",
"text" : // acceleratedInitial-3m-1
{
"status" : "generated",
"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>"
},
"collection" : {
"collectedDateTime" : "2020-06"
},
"processing" : [
{
"description" : "No storage"
},
{
"description" : "40°C/75% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:f958e1e9-6023-4e39-2ffe-a9c8f135a2dd",
"resource" : {
"resourceType" : "Observation",
"id" : "f958e1e9-6023-4e39-2ffe-a9c8f135a2dd",
"text" : // Accelerated40C-3m
{
"status" : "extensions",
"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>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3m-1-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Doesn't comply"
}
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3m-1-Impurity1",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.113,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3m-1-Impurity2",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.213,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3m-1-ImpurityUnspecified",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.0513,
"comparator" : "<",
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any Unspecified Impurity"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3m-1-ImpurityTotal",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.813,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total Impurities"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3m-1-Assay",
"instantiatesReference" : {
"reference" : "ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
]
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.113,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3m-1-Identification",
"instantiatesReference" : {
"reference" : "ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
}
],
"extension" : [
// 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
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityAccelerated40X-3
{
"text" : "Accelerated - 40°C/67% RH - 3 months (X)"
},
"subject" : {
"reference" : "Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"specimen" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"reference" : "Specimen/b04c9321-069c-4da8-8ed0-86337ea22c30"
},
"hasMember" : [
// Specimen/acceleratedInitial-3m-1
{
"reference" : "#Accelerated40C-3m-1-Description"
},
{
"reference" : "#Accelerated40C-3m-1-Assay"
},
{
"reference" : "#Accelerated40C-3m-1-Impurity1"
},
{
"reference" : "#Accelerated40C-3m-1-Impurity2"
},
{
"reference" : "#Accelerated40C-3m-1-ImpurityUnspecified"
},
{
"reference" : "#Accelerated40C-3m-1-ImpurityTotal"
},
{
"reference" : "#Accelerated40C-3m-1-Identification"
}
]
}
},
{
"fullUrl" : "urn:uuid:62c1b1b4-8d15-26d2-57f9-25a2f60b6181",
"resource" : {
"resourceType" : "Organization",
"id" : "62c1b1b4-8d15-26d2-57f9-25a2f60b6181",
"text" : // manufacturer
{
"status" : "generated",
"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:\u00a03003040516</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>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3003040516"
}
],
"name" : "AAA Molybdenum Products, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"7233 W 116th Pl",
"Ste C"
],
"city" : "Broomfield",
"state" : "Colorado",
"postalCode" : "80020",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:6049d921-9935-90b7-4efc-894a66483c00",
"resource" : {
"resourceType" : "Organization",
"id" : "6049d921-9935-90b7-4efc-894a66483c00",
"text" : // tester
{
"status" : "generated",
"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:\u00a03007270600</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>"
},
"identifier" : [
// could also use assigner here, for #74
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3007270600"
}
],
"name" : "Advanced Analytical Testing Laboratories Inc.",
"contact" : [
{
"address" : {
"line" : [
"30 Silverline Drive"
],
"city" : "North Brunswick",
"state" : "New Jersey",
"postalCode" : "08902",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:2e3a85b5-790a-a108-3627-edf0ec6f1210",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "2e3a85b5-790a-a108-3627-edf0ec6f1210",
"text" : // substance1
{
"status" : "generated",
"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:\u00a04444455555</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>"
},
"identifier" : [
{
"system" : "http://example.company.org/companySubstanceIdentifier",
"value" : "4444455555"
}
],
"manufacturer" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq",
"valueCoding" : {
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productSiteUtilizationType-local-pq",
"code" : "Release stability",
"display" : "Release stability"
}
}
],
"reference" : "Organization/62c1b1b4-8d15-26d2-57f9-25a2f60b6181"
}
],
"name" : [
// Organization/manufacturer
{
"name" : "Stelbatolol"
}
]
}
},
{
"fullUrl" : "urn:uuid:e2359a4e-3091-23f8-2242-87e701830d55",
"resource" : {
"resourceType" : "Organization",
"id" : "e2359a4e-3091-23f8-2242-87e701830d55",
"text" : // substance-manufacturer
{
"status" : "generated",
"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:\u00a03003040516</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>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3003040516"
}
],
"name" : "AAA Molybdenum Products, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"7233 W 116th Pl",
"Ste C"
],
"city" : "Broomfield",
"state" : "Colorado",
"postalCode" : "80020",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08",
"resource" : {
"resourceType" : "Organization",
"id" : "378fbe5f-5926-3a5c-4c64-5428df877b08",
"text" : // testing lab
// 378fbe5f-5926-3a5c-4c64-5428df877b08
{
"status" : "generated",
"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>"
},
"name" : "Testing Lab"
}
},
{
"fullUrl" : "urn:uuid:a3fdc23b-6c16-2e65-481e-3fc895b37b87",
"resource" : {
"resourceType" : "Substance",
"id" : "a3fdc23b-6c16-2e65-481e-3fc895b37b87",
"text" : // actual-batch-substance
{
"status" : "extensions",
"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:\u00a0CAT1</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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-01"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 120,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
// could also be C185328 Stability Study?
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/e2359a4e-3091-23f8-2242-87e701830d55"
}
},
// Organization/substance-manufacturer
{
"url" : "container",
"extension" : [
{
"url" : "type",
"valueCodeableConcept" : {
"text" : "packaged in LDPE bags within HDPE drums"
}
}
]
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
{
"value" : "CAT1"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210"
}
}
}
},
// SubstanceDefinition/substance1
{
"fullUrl" : "urn:uuid:cbcecab6-374c-396f-29be-877da7285e8d",
"resource" : {
"resourceType" : "Substance",
"id" : "cbcecab6-374c-396f-29be-877da7285e8d",
"text" : // actual-batch-substance-2
{
"status" : "extensions",
"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:\u00a0CAT2</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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-02"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 120,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
// could also be C185328 Stability Study?
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/e2359a4e-3091-23f8-2242-87e701830d55"
}
}
]
},
// Organization/substance-manufacturer
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
{
"value" : "CAT2"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210"
}
}
}
},
// SubstanceDefinition/substance1
{
"fullUrl" : "urn:uuid:ae1f3b4c-4f14-1460-6903-7260959ea2cd",
"resource" : {
"resourceType" : "Substance",
"id" : "ae1f3b4c-4f14-1460-6903-7260959ea2cd",
"text" : // actual-batch-substance-3
{
"status" : "extensions",
"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:\u00a0CAT3</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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-03"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 120,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
// could also be C185328 Stability Study?
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/e2359a4e-3091-23f8-2242-87e701830d55"
}
}
]
},
// Organization/substance-manufacturer
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
{
"value" : "CAT3"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210"
}
}
}
}
]
}
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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