Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ 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:SubstanceDefinition ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "d8242262-2187-4ea2-907f-b66752202b46"] ; #
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\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"d8242262-2187-4ea2-907f-b66752202b46\"> </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 "d8242262-2187-4ea2-907f-b66752202b46" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Carrageenan</p><p><b>classification</b>: Structurally Diverse Substance - Herbal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ema-dummy.html\">Dummy EMA Codesystem</a>#9)</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\">Dummy NCIT Codesystem</a>#C134009)</span></p><p><b>manufacturer</b>: <a href=\"Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-4b565cf3-5353-48af-8cd6-5ccf4e9fd579\">urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579</a></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>5C69YCD2YJ <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (gsrs.ncats.nih.gov#5C69YCD2YJ)</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>Carrageenan</td><td>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</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>Plant <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C14258)</span></td><td>palmaria <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>palmata <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>United States of America <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#USA)</span></td></tr></table></div>"
] ; #
fhir:identifier ( [
fhir:value [ fhir:v "Carrageenan" ]
] ) ; #
fhir:classification ( [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ema-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "9" ] ;
fhir:display [ fhir:v "Structurally Diverse Substance - Herbal" ] ] )
] ) ; #
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:manufacturer ( [
fhir:reference [ fhir:v "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579" ]
] ) ; #
fhir:code ( [
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "5C69YCD2YJ" ] ] ) ]
] ) ; #
fhir:name ( [
fhir:name [ fhir:v "Carrageenan" ] ;
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 "C14258" ] ;
fhir:display [ fhir:v "Plant" ] ] ) ] ;
fhir:genus [
fhir:text [ fhir:v "palmaria" ] ] ;
fhir:species [
fhir:text [ fhir:v "palmata" ] ] ;
( fhir:countryOfOrigin [
( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "USA" ] ;
fhir:display [ fhir:v "United States of America" ] ] ) ] )
] . #
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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