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@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "7cdbb042-9275-4599-a1fe-08877846bf94"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151> ] ) ] ; # fhir:identifier [ fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ; fhir:value [ fhir:v "urn:uuid:813b4312-8b6d-42cc-9b8c-8bb6463388cc" ] ] ; # fhir:type [ fhir:v "document"] ; # fhir:timestamp [ fhir:v "2024-01-01T19:42:35.255Z"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a> ) ] ) . # <urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4> a fhir:Composition ; fhir:id [ fhir:v "4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 4bd1ed57-852b-42be-a9b0-355f8a2aa7d4</b></p><a name=\"4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><a name=\"hc4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><a name=\"4bd1ed57-852b-42be-a9b0-355f8a2aa7d4-en-US\"> </a><p><b>identifier</b>: CochinealSpecificationComposition</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use ich_3.2.p.4}\">Control of Excipients</span></p><p><b>date</b>: 2024-01-01 19:42:35+0000</p><p><b>author</b>: <a href=\"Bundle-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><p><b>title</b>: Cochineal specification Composition Example</p></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "CochinealSpecificationComposition" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"^^xsd:anyURI ] ; fhir:code [ fhir:v "ich_3.2.p.4" ] ; fhir:display [ fhir:v "Control of Excipients" ] ] ) ] ; # fhir:date [ fhir:v "2024-01-01T19:42:35.254Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a" ] ] ) ; # fhir:title [ fhir:v "Cochineal specification Composition Example"] ; # fhir:section ( [ fhir:title [ fhir:v "32P40" ] ; ( fhir:entry [ fhir:reference [ fhir:v "urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e" ] ] ) ] ) . # <urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e> a fhir:PlanDefinition ; fhir:id [ fhir:v "37bf5cc0-33bf-478b-b84e-ccb35143ef6e"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </a>\n<div>\n <table class=\"grid dict\">\n \n <tr>\n <th scope=\"row\"><b>Id: </b></th>\n <td style=\"padding-left: 4px;\">37bf5cc0-33bf-478b-b84e-ccb35143ef6e</td>\n </tr>\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Version: </b></th>\n <td style=\"padding-left: 4px;\">1.0</td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\">\n <b>\n \n \n \n </b>\n </th>\n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <span>CochinealSpecification</span>\n </p>\n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Title: </b></th>\n <td style=\"padding-left: 4px;\">Cochineal specification Example</td>\n </tr>\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Type: </b></th>\n <td style=\"padding-left: 4px;\">\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>workflow-definition</span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>display: </b> <span>Workflow Definition</span>\n </p>\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>C133931</span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>\n </p>\n \n \n \n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Subject: </b></th>\n \n \n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <b>reference: </b> <span>urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf</span>\n </p>\n \n \n \n </td>\n \n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Date: </b></th>\n <td style=\"padding-left: 4px;\">2023-12-01</td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Actions: </b></th>\n <td style=\"padding-left: 4px;\">\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b>Single Stage Appearance:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Identification:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage pH:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Residue on Ignition:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Impurities:</b> \n \n <br/>\n \n \n \n <b>Then:</b>\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b> Unidentified Impurities:</b>\n \n \n <br/>\n \n \n \n <b>Then:</b> <i>Additional sub-actions not displayed</i>\n \n </td>\n </tr>\n \n </table>\n \n </td>\n </tr>\n \n </table>\n </td>\n </tr>\n \n </table>\n</div>\n</div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48660" ] ; fhir:display [ fhir:v "Not Applicable" ] ] ) ] ] ) ; # fhir:identifier ( [ fhir:value [ fhir:v "CochinealSpecification" ] ] ) ; # fhir:version [ fhir:v "1.0"] ; # fhir:title [ fhir:v "Cochineal specification Example"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/plan-definition-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "workflow-definition" ] ; fhir:display [ fhir:v "Workflow Definition" ] ] [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C133931" ] ; fhir:display [ fhir:v "Raw Materials/Excipients/Intermediates/Reagents" ] ] ) ] ; # fhir:status [ fhir:v "active"] ; # fhir:subject [ a fhir:Reference ; fhir:reference [ fhir:v "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf" ] ] ; # fhir:date [ fhir:v "2023-12-01"^^xsd:date] ; # fhir:goal ( [ fhir:id [ fhir:v "e900181a-876c-4ed6-ac96-d5a73c3d6767" ] ; fhir:description [ fhir:text [ fhir:v "White Solid" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ fhir:v "White solid" ] ] ) ] [ fhir:id [ fhir:v "21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c" ] ; fhir:description [ fhir:text [ fhir:v "IR spectrum conforms to reference standard" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ fhir:v "IR spectrum conforms to reference standard" ] ] ) ] [ fhir:id [ fhir:v "1f476689-f440-4a77-9e9c-0615af3571eb" ] ; fhir:description [ fhir:text [ fhir:v "pH 3.4-4.3" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:_target [ ( fhir:modifierExtension [ ( fhir:extension [ fhir:url [ fhir:v "low"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "3.4"^^xsd:decimal ] ; fhir:comparator [ fhir:v ">=" ] ; fhir:unit [ fhir:v "[pH]" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "[pH]" ] ] ] [ fhir:url [ fhir:v "high"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "4.3"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "[pH]" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "[pH]" ] ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"^^xsd:anyURI ] ] ) ] ) ] [ fhir:id [ fhir:v "9c0d2619-4505-4e6b-a801-bc30f84bc3e2" ] ; fhir:description [ fhir:text [ fhir:v "residue <= 0.21%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "0.21"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] ) ] [ fhir:id [ fhir:v "fc230a97-fd1a-4017-8603-822c5430a217" ] ; fhir:description [ fhir:text [ fhir:v "Formaldehyde NMT 1.5%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "1.5"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] ) ] [ fhir:id [ fhir:v "8d6688e0-7412-4d64-afe8-b73d8aec596e" ] ; fhir:description [ fhir:text [ fhir:v "Impurity C NMT 2%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "2"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] ) ] [ fhir:id [ fhir:v "f8e8343d-a37d-4b91-916b-f58d6947dc9c" ] ; fhir:description [ fhir:text [ fhir:v "Unspecified Impurity NMT 0.10 % w/w" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "0.1"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "percent WeightToWeight" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%{WeightToWeight}" ] ] ] ) ] [ fhir:id [ fhir:v "be7abaa1-0769-4560-af76-326e07d1df9a" ] ; fhir:description [ fhir:text [ fhir:v "Total Impurities" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "0.7"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] ) ] [ fhir:id [ fhir:v "cfdd469d-020b-4047-946f-f513d58f007f" ] ; fhir:description [ fhir:text [ fhir:v "Total Unidentified Impurities NMT 0.3%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "0.3"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%" ] ] ] ) ] [ fhir:id [ fhir:v "c5eea380-416f-4d19-a21e-c021f3c7c543" ] ; fhir:description [ fhir:text [ fhir:v "RRT 2.2 NMT 0.10% w/w" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "0.1"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "percent WeightToWeight" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%{WeightToWeight}" ] ] ] ) ] [ fhir:id [ fhir:v "41e19fa2-f568-443e-8bc1-6b0a6dca9d0c" ] ; fhir:description [ fhir:text [ fhir:v "RRT 2.4 NMT 0.10% w/w" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "0.1"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "percent WeightToWeight" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%{WeightToWeight}" ] ] ] ) ] [ fhir:id [ fhir:v "e493cb3d-45b6-4463-b9b6-e588c51e032c" ] ; fhir:description [ fhir:text [ fhir:v "RRT 3.41 NMT 0.10% w/w" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "0.2"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "percent WeightToWeight" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "%{WeightToWeight}" ] ] ] ) ] ) ; # fhir:action ( [ fhir:linkId [ fhir:v "b9359ce8-73f3-45c5-9674-98d850053aa2" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Appearance" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:positiveInteger ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C205026" ] ; fhir:display [ fhir:v "Organoleptic" ] ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:positiveInteger ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C138990" ] ; fhir:display [ fhir:v "Description/Appearance" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-101" ] ] ) ; ( fhir:goalId [ fhir:v "e900181a-876c-4ed6-ac96-d5a73c3d6767" ] ) ] [ fhir:linkId [ fhir:v "443ed163-7a7b-4d48-9462-be5532158411" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Identification" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "FTIR" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:positiveInteger ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C138993" ] ; fhir:display [ fhir:v "Identification" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-102" ] ] ) ; ( fhir:goalId [ fhir:v "21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c" ] ) ] [ fhir:linkId [ fhir:v "058193ee-dd86-4c63-9f47-7b0608abbca4" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "pH" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:positiveInteger ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C205029" ] ; fhir:display [ fhir:v "pH" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-103" ] ] ) ; ( fhir:goalId [ fhir:v "1f476689-f440-4a77-9e9c-0615af3571eb" ] ) ] [ fhir:linkId [ fhir:v "940c8db4-9ed1-416e-84ec-9f9e143be8ab" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Residue on Ignition" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96102" ] ; fhir:display [ fhir:v "Compendial" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:positiveInteger ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134276" ] ; fhir:display [ fhir:v "Residue on Ignition" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "USP <281>" ] ] ) ; ( fhir:goalId [ fhir:v "9c0d2619-4505-4e6b-a801-bc30f84bc3e2" ] ) ] [ fhir:linkId [ fhir:v "9fca0a37-6d10-4273-a966-c026ab6eb07d" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Impurities" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "FTIR" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:positiveInteger ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C204971" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-104" ] ] ) ; ( fhir:goalId [ fhir:v "fc230a97-fd1a-4017-8603-822c5430a217" ] [ fhir:v "8d6688e0-7412-4d64-afe8-b73d8aec596e" ] [ fhir:v "f8e8343d-a37d-4b91-916b-f58d6947dc9c" ] [ fhir:v "be7abaa1-0769-4560-af76-326e07d1df9a" ] [ fhir:v "cfdd469d-020b-4047-946f-f513d58f007f" ] ) ; ( fhir:action [ fhir:title [ fhir:v "Unidentified Impurities" ] ; ( fhir:action [ fhir:prefix [ fhir:v "RRT" ] ; fhir:title [ fhir:v "2.2" ] ; ( fhir:goalId [ fhir:v "c5eea380-416f-4d19-a21e-c021f3c7c543" ] ) ] [ fhir:prefix [ fhir:v "RRT" ] ; fhir:title [ fhir:v "2.4" ] ; ( fhir:goalId [ fhir:v "41e19fa2-f568-443e-8bc1-6b0a6dca9d0c" ] ) ] [ fhir:prefix [ fhir:v "RRT" ] ; fhir:title [ fhir:v "3.41" ] ; ( fhir:goalId [ fhir:v "e493cb3d-45b6-4463-b9b6-e588c51e032c" ] ) ] ) ] ) ] ) . # <urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "278736ef-2ddf-49e4-895c-3a9f34db36cf"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 278736ef-2ddf-49e4-895c-3a9f34db36cf</b></p><a name=\"278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><a name=\"hc278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><a name=\"278736ef-2ddf-49e4-895c-3a9f34db36cf-en-US\"> </a><p><b>identifier</b>: Cochineal</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}\">Company Standard</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov TZ8Z31B35M}\">TZ8Z31B35M</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>Cochineal</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td><td><span title=\"Codes:\">Dactylopius</span></td><td><span title=\"Codes:\">cochineal</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 TUR}\">Turkey</span></td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "Cochineal" ] ] ) ; # fhir:classification ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48807" ] ; fhir:display [ fhir:v "Chemical" ] ] ) ] ) ; # fhir:grade ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134009" ] ; fhir:display [ fhir:v "Company Standard" ] ] ) ] ) ; # fhir:code ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ; fhir:code [ fhir:v "TZ8Z31B35M" ] ] ) ] ] ) ; # fhir:name ( [ fhir:name [ fhir:v "Cochineal" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C203355" ] ; fhir:display [ fhir:v "GSRS Preferred Term" ] ] ) ] ; fhir:preferred [ fhir:v "true"^^xsd:boolean ] ] ) ; # fhir:sourceMaterial [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48807" ] ; fhir:display [ fhir:v "Chemical" ] ] ) ] ; fhir:genus [ fhir:text [ fhir:v "Dactylopius" ] ] ; fhir:species [ fhir:text [ fhir:v "cochineal" ] ] ; ( fhir:countryOfOrigin [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "TUR" ] ; fhir:display [ fhir:v "Turkey" ] ] ) ] ) ] . # <urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a> a fhir:Organization ; fhir:id [ fhir:v "4f3e9af1-306b-4fad-bf04-7881400b266a"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a-en-US\"> </a><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</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>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134003" ] ; fhir:display [ fhir:v "DUNS" ] ] ) ] ; fhir:system [ fhir:v "urn:oid:1.3.6.1.4.1.519.1"^^xsd:anyURI ] ; fhir:value [ fhir:v "143265222" ] ] ) ; # fhir:name [ fhir:v "Wunderwerke"] ; # fhir:contact ( [ fhir:address [ fhir:type [ fhir:v "postal" ] ; fhir:text [ fhir:v "Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478" ] ; ( fhir:line [ fhir:v "123 Scenic Road" ] ) ; fhir:city [ fhir:v "Bridgeport" ] ; fhir:state [ fhir:v "CT" ] ; fhir:postalCode [ fhir:v "65478" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . #
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-12
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