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:SubstanceDefinition ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "21b6b724-507e-4cf4-a462-93334b98d166"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure> ] )
] ; #
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=\"21b6b724-507e-4cf4-a462-93334b98d166\"> </a><a name=\"hc21b6b724-507e-4cf4-a462-93334b98d166\"> </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 "21b6b724-507e-4cf4-a462-93334b98d166" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-substance-nomenclature-structure.html\">Substance General Information</a></p></div><p><b>identifier</b>: levoThyroxine</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>manufacturer</b>: <a href=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e875ef93-a730-4c44-bead-53663ae7f501\">urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501</a></p><p><b>supplier</b>: <a href=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e165f057-5eed-4e64-8328-4438fc88fb1b\">urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b</a></p><h3>MolecularWeights</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Amount</b></td></tr><tr><td style=\"display: none\">*</td><td>798.85 u<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C41127 = 'u')</span></td></tr></table><blockquote><p><b>structure</b></p><p><b>technique</b>: NMR Spectroscopy <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: InChI File (small molecule) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C54683)</span></p><p><b>representation</b>: YDTFRJLNMPSCFM-YDALLXLXSA-M</p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: SMILES <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C54684)</span></p><p><b>representation</b>: [Na+].N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O</p></blockquote><blockquote><p><b>representation</b></p><p><b>document</b>: <a href=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-d94ad7ac-b935-432f-bc68-312b6b8dcca7\">urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7</a></p></blockquote><blockquote><p><b>representation</b></p><p><b>document</b>: <a href=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-22bd989e-8056-494f-9bc1-195d13428179\">urn:uuid:22bd989e-8056-494f-9bc1-195d13428179</a></p></blockquote></blockquote><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>054I36CPMN <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>#054I36CPMN)</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: 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></p><p><b>preferred</b>: true</p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate</p><p><b>type</b>: IUPAC Name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C203356)</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: 55-03-8</p><p><b>type</b>: CAS Number <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C54682)</span></p></blockquote><h3>Relationships</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>SubstanceDefinition[x]</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-832f22b4-6f0c-41f8-9b7d-f26f55e9973c\">urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c</a></td><td>Polymorph <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
] ; #
fhir:identifier ( [
fhir:value [ fhir:v "levoThyroxine" ]
] ) ; #
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:manufacturer ( [
fhir:reference [ fhir:v "urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501" ]
] ) ; #
fhir:supplier ( [
fhir:reference [ fhir:v "urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b" ]
] ) ; #
fhir:molecularWeight ( [
fhir:amount [
fhir:value [ fhir:v "798.85"^^xsd:decimal ] ;
fhir:unit [ fhir:v "u" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C41127" ] ]
] ) ; #
fhir:structure [
( fhir:technique [
fhir:text [ fhir:v "NMR Spectroscopy" ] ] ) ;
( fhir:representation [
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 "C54683" ] ;
fhir:display [ fhir:v "InChI File (small molecule)" ] ] ) ] ;
fhir:representation [ fhir:v "YDTFRJLNMPSCFM-YDALLXLXSA-M" ] ] [
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 "C54684" ] ;
fhir:display [ fhir:v "SMILES" ] ] ) ] ;
fhir:representation [ fhir:v "[Na+].N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O" ] ] [
fhir:document [
fhir:reference [ fhir:v "urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7" ] ] ] [
fhir:document [
fhir:reference [ fhir:v "urn:uuid:22bd989e-8056-494f-9bc1-195d13428179" ] ] ] )
] ; #
fhir:code ( [
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "054I36CPMN" ] ] ) ]
] ) ; #
fhir:name ( [
fhir:name [ fhir:v "LEVOTHYROXINE SODIUM ANHYDROUS" ] ;
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:name [ fhir:v "sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate" ] ;
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 "C203356" ] ;
fhir:display [ fhir:v "IUPAC Name" ] ] ) ]
] [
fhir:name [ fhir:v "55-03-8" ] ;
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 "C54682" ] ;
fhir:display [ fhir:v "CAS Number" ] ] ) ]
] ) ; #
fhir:relationship ( [
fhir:substanceDefinition [
a fhir:Reference ;
fhir:reference [ fhir:v "urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c" ] ] ;
fhir:type [
fhir:text [ fhir:v "Polymorph" ] ]
] ) . #
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
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change