Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- 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:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version"^^xsd:anyURI ] ; fhir:value [ fhir:v "0.1.24" ] ] ) ; 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><b>Generated Narrative: Composition</b><a name=\"4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><a name=\"hc4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </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 Composition "4bd1ed57-852b-42be-a9b0-355f8a2aa7d4" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-sp4151.html\">eCTD Specification Composition</a></p></div><p><b>identifier</b>: CochinealSpecificationComposition</p><p><b>status</b>: final</p><p><b>type</b>: Quality Specification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-comp-section-types.html\">Code System PQCMC Comp Section Types</a>#SP4151)</span></p><p><b>date</b>: 2024-01-01 19:42:35+0000</p><p><b>author</b>: See on this page: urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a</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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"^^xsd:anyURI ] ; fhir:code [ fhir:v "SP4151" ] ; fhir:display [ fhir:v "Quality Specification" ] ] ) ] ; # 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:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"^^xsd:anyURI ] ; fhir:code [ fhir:v "32P40" ] ; fhir:display [ fhir:v "Product Control of Excipients" ] ] ) ] ; ( 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><p><b>Generated Narrative: PlanDefinition</b><a name=\"37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </a><a name=\"hc37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </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 "37bf5cc0-33bf-478b-b84e-ccb35143ef6e" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-quality-specification.html\">Quality Specification</a></p></div><p><b>Specification Type</b>: Raw Materials/Excipients/Intermediates/Reagents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C133931)</span></p><p><b>identifier</b>: CochinealSpecification</p><p><b>version</b>: 1.0</p><p><b>title</b>: Cochineal specification Example</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48660 "Not Applicable")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf</p><p><b>date</b>: 2023-12-01</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>e900181a-876c-4ed6-ac96-d5a73c3d6767</blockquote><p><b>description</b>: White Solid <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>White solid <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c</blockquote><p><b>description</b>: IR spectrum conforms to reference standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>IR spectrum conforms to reference standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>1f476689-f440-4a77-9e9c-0615af3571eb</blockquote><p><b>description</b>: pH 3.4-4.3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>3.4-4.3 [pH]</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>9c0d2619-4505-4e6b-a801-bc30f84bc3e2</blockquote><p><b>description</b>: residue <= 0.21% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.21 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>fc230a97-fd1a-4017-8603-822c5430a217</blockquote><p><b>description</b>: Formaldehyde NMT 1.5% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>1.5 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>8d6688e0-7412-4d64-afe8-b73d8aec596e</blockquote><p><b>description</b>: Impurity C NMT 2% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>f8e8343d-a37d-4b91-916b-f58d6947dc9c</blockquote><p><b>description</b>: Unspecified Impurity NMT 0.10 % w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.1 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>be7abaa1-0769-4560-af76-326e07d1df9a</blockquote><p><b>description</b>: Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.7 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>cfdd469d-020b-4047-946f-f513d58f007f</blockquote><p><b>description</b>: Total Unidentified Impurities NMT 0.3% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.3 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>c5eea380-416f-4d19-a21e-c021f3c7c543</blockquote><p><b>description</b>: RRT 2.2 NMT 0.10% w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.1 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>41e19fa2-f568-443e-8bc1-6b0a6dca9d0c</blockquote><p><b>description</b>: RRT 2.4 NMT 0.10% w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.1 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>e493cb3d-45b6-4463-b9b6-e588c51e032c</blockquote><p><b>description</b>: RRT 3.41 NMT 0.10% w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.2 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>linkId</b>: b9359ce8-73f3-45c5-9674-98d850053aa2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Appearance</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Organoleptic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC6)</span>, Description/Appearance <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#SUBC20)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-101</td></tr></table><p><b>goalId</b>: e900181a-876c-4ed6-ac96-d5a73c3d6767</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>linkId</b>: 443ed163-7a7b-4d48-9462-be5532158411</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Identification</p><p><b>code</b>: FTIR <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC7)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-102</td></tr></table><p><b>goalId</b>: 21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>linkId</b>: 058193ee-dd86-4c63-9f47-7b0608abbca4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: pH</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: pH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC23)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-103</td></tr></table><p><b>goalId</b>: 1f476689-f440-4a77-9e9c-0615af3571eb</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>linkId</b>: 940c8db4-9ed1-416e-84ec-9f9e143be8ab</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Residue on Ignition</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Residue on Ignition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC38)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>USP <281></td></tr></table><p><b>goalId</b>: 9c0d2619-4505-4e6b-a801-bc30f84bc3e2</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 5</p><p><b>linkId</b>: 9fca0a37-6d10-4273-a966-c026ab6eb07d</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Impurities</p><p><b>code</b>: FTIR <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC53)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-104</td></tr></table><p><b>goalId</b>: fc230a97-fd1a-4017-8603-822c5430a217, 8d6688e0-7412-4d64-afe8-b73d8aec596e, f8e8343d-a37d-4b91-916b-f58d6947dc9c, be7abaa1-0769-4560-af76-326e07d1df9a, cfdd469d-020b-4047-946f-f513d58f007f</p><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 5.1</p><p><b>title</b>: Unidentified Impurities</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C133931" ] ; fhir:display [ fhir:v "Raw Materials/Excipients/Intermediates/Reagents" ] ] ) ] ] ) ; # 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48660" ] ; fhir:display [ fhir:v "Not Applicable" ] ] ) ] ; # 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Range ; fhir:low [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61583" ] ; fhir:display [ fhir:v "NLT (not less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "3.4"^^xsd:decimal ] ; fhir:unit [ fhir:v "[pH]" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C45997" ] ] ; fhir:high [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "4.3"^^xsd:decimal ] ; fhir:unit [ fhir:v "[pH]" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C45997" ] ] ] ] ) ] [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.21"^^xsd:decimal ] ; fhir:unit [ fhir:v "%" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "1.5"^^xsd:decimal ] ; fhir:unit [ fhir:v "%" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "2"^^xsd:decimal ] ; fhir:unit [ fhir:v "%" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.1"^^xsd:decimal ] ; fhir:unit [ fhir:v "%{WeightToWeight}" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48528" ] ] ] ) ] [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.7"^^xsd:decimal ] ; fhir:unit [ fhir:v "%" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.3"^^xsd:decimal ] ; fhir:unit [ fhir:v "%" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.1"^^xsd:decimal ] ; fhir:unit [ fhir:v "%{WeightToWeight}" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48528" ] ] ] ) ] [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.1"^^xsd:decimal ] ; fhir:unit [ fhir:v "%{WeightToWeight}" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48528" ] ] ] ) ] [ 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.2"^^xsd:decimal ] ; fhir:unit [ fhir:v "%{WeightToWeight}" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48528" ] ] ] ) ] ) ; # fhir:action ( [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:decimal ] ] ) ; 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC6" ] ; 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:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "SUBC20" ] ; 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:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:decimal ] ] ) ; 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC7" ] ; 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:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "3"^^xsd:decimal ] ] ) ; 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC23" ] ; 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:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "4"^^xsd:decimal ] ] ) ; 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC38" ] ; 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:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "5"^^xsd:decimal ] ] ) ; 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC53" ] ; 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:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "5.1"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Unidentified Impurities" ] ; ( fhir:action [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "5.11"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "RRT" ] ; fhir:title [ fhir:v "2.2" ] ; ( fhir:goalId [ fhir:v "c5eea380-416f-4d19-a21e-c021f3c7c543" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "5.12"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "RRT" ] ; fhir:title [ fhir:v "2.4" ] ; ( fhir:goalId [ fhir:v "41e19fa2-f568-443e-8bc1-6b0a6dca9d0c" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "5.13"^^xsd:decimal ] ] ) ; 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><b>Generated Narrative: SubstanceDefinition</b><a name=\"278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><a name=\"hc278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </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 "278736ef-2ddf-49e4-895c-3a9f34db36cf" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Cochineal</p><p><b>classification</b>: Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>grade</b>: Company Standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134009)</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>TZ8Z31B35M <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#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>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C203355)</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>Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></td><td>Dactylopius <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>cochineal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>Turkey <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#TUR)</span></td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "Cochineal" ] ] ) ; # fhir:classification ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48807" ] ; fhir:display [ fhir:v "Chemical" ] ] ) ] ) ; # fhir:grade ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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-sponsor-organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-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><b>Generated Narrative: Organization</b><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </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 "4f3e9af1-306b-4fad-bf04-7881400b266a" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-sponsor-organization.html\">Sponsor Organization</a></p></div><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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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: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#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-04
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