Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 2.0.0 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

## : 3.2.S.1 Bundle - TTL Representation

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    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
    @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 "GeneralInformationBundle"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s10"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s10>     ] )
      ] ; #
      fhir:identifier [
    fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "urn:uuid:1bf43677-1c61-41dd-93c2-8ec7f327d0f1" ]
      ] ; #
      fhir:type [ fhir:v "document"] ; #
      fhir:timestamp [ fhir:v "2023-12-15T22:19:47.022Z"^^xsd:dateTime] ; #
      fhir:entry ( [
    fhir:fullUrl [ fhir:v "urn:uuid:260f5aa3-23d2-4999-8e5f-70f247390ee5"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:260f5aa3-23d2-4999-8e5f-70f247390ee5> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:21b6b724-507e-4cf4-a462-93334b98d166"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:21b6b724-507e-4cf4-a462-93334b98d166> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:22bd989e-8056-494f-9bc1-195d13428179"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:22bd989e-8056-494f-9bc1-195d13428179> )
      ] ) . #

    <urn:uuid:260f5aa3-23d2-4999-8e5f-70f247390ee5> a fhir:Composition ;
      fhir:id [ fhir:v "260f5aa3-23d2-4999-8e5f-70f247390ee5"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s10"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s10>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_260f5aa3-23d2-4999-8e5f-70f247390ee5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 260f5aa3-23d2-4999-8e5f-70f247390ee5</b></p><a name=\"260f5aa3-23d2-4999-8e5f-70f247390ee5\"> </a><a name=\"hc260f5aa3-23d2-4999-8e5f-70f247390ee5\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-32s10.html\">eCTD Substance General Information</a></p></div><p><b>identifier</b>: Substance General - levoThyroxine</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.s.1}\">m3.2.s.1 general information</span></p><p><b>date</b>: 2023-12-15 22:19:47+0000</p><p><b>author</b>: <a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-b69435a0-45c6-4d44-9fde-b354e17408d7\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><p><b>title</b>: eCTD Substance General Information for levoThyroxine</p></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "Substance General - levoThyroxine" ]
      ] ) ; #
      fhir:status [ fhir:v "final"] ; #
      fhir:type [
        ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/ICHContextOfUse"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "ich_3.2.s.1" ] ;
    fhir:display [ fhir:v "m3.2.s.1 general information" ]     ] )
      ] ; #
      fhir:date [ fhir:v "2023-12-15T22:19:47.022Z"^^xsd:dateTime] ; #
      fhir:author ( [
    fhir:reference [ fhir:v "urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7" ]
      ] ) ; #
      fhir:title [ fhir:v "eCTD Substance General Information for levoThyroxine"] ; #
      fhir:section ( [
    fhir:title [ fhir:v "Drug Substance Nomeclature and Structure for levoThyroxine" ] ;
        ( fhir:entry [
    fhir:reference [ fhir:v "urn:uuid:21b6b724-507e-4cf4-a462-93334b98d166" ]     ] )
      ] ) . #

    <urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7> a fhir:Organization ;
      fhir:id [ fhir:v "b69435a0-45c6-4d44-9fde-b354e17408d7"] ; #
      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_b69435a0-45c6-4d44-9fde-b354e17408d7\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization b69435a0-45c6-4d44-9fde-b354e17408d7</b></p><a name=\"b69435a0-45c6-4d44-9fde-b354e17408d7\"> </a><a name=\"hcb69435a0-45c6-4d44-9fde-b354e17408d7\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Large Life</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>123 Broad Way, New York, NY, United States</td></tr></table></div>"^^rdf:XMLLiteral
      ] ; #
      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 "Large Life"] ; #
      fhir:contact ( [
    fhir:address [
    fhir:type [ fhir:v "postal" ] ;
    fhir:text [ fhir:v "123 Broad Way, New York, NY, United States" ] ;
          ( fhir:line [ fhir:v "123 Broad Way" ] ) ;
    fhir:city [ fhir:v "New York" ] ;
    fhir:state [ fhir:v "NY" ] ;
    fhir:postalCode [ fhir:v "10020" ] ;
    fhir:country [ fhir:v "USA" ]     ]
      ] ) . #

    <urn:uuid:21b6b724-507e-4cf4-a462-93334b98d166> a fhir:SubstanceDefinition ;
      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\"><a name=\"SubstanceDefinition_21b6b724-507e-4cf4-a462-93334b98d166\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 21b6b724-507e-4cf4-a462-93334b98d166</b></p><a name=\"21b6b724-507e-4cf4-a462-93334b98d166\"> </a><a name=\"hc21b6b724-507e-4cf4-a462-93334b98d166\"> </a><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\"/><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>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>manufacturer</b>: <a href=\"Bundle-BatchFormulaBundle.html#urn-uuid-e875ef93-a730-4c44-bead-53663ae7f501\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-e165f057-5eed-4e64-8328-4438fc88fb1b\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</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 unified atomic mass unit<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM  codeu = 'u')</span></td></tr></table><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title=\"Codes:\">NMR Spectroscopy</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: YDTFRJLNMPSCFM-YDALLXLXSA-M</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54683}\">InChI File (small molecule)</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</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><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}\">SMILES</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54273}\">Picture</span></p><p><b>document</b>: <a href=\"Bundle-GeneralInformationBundle.html#urn-uuid-d94ad7ac-b935-432f-bc68-312b6b8dcca7\">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C103240}\">CHEMICAL STRUCTURE</span></p><p><b>document</b>: <a href=\"Bundle-GeneralInformationBundle.html#urn-uuid-22bd989e-8056-494f-9bc1-195d13428179\">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</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><span title=\"Codes:{http://fdasis.nlm.nih.gov 054I36CPMN}\">054I36CPMN</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</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>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203356}\">IUPAC Name</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: 55-03-8</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54682}\">CAS Number</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-GeneralInformationBundle.html#urn-uuid-832f22b4-6f0c-41f8-9b7d-f26f55e9973c\">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></td><td><span title=\"Codes:\">Polymorph</span></td></tr></table></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "levoThyroxine" ]
      ] ) ; #
      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: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 ] ;
    fhir:unit [ fhir:v "unified atomic mass unit" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "u" ]     ]
      ] ) ; #
      fhir:structure [
        ( fhir:technique [
    fhir:text [ fhir:v "NMR Spectroscopy" ]     ] ) ;
        ( fhir:representation [
    fhir:type [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C45253" ]         ] )       ] ;
    fhir:representation [ fhir:v "YDTFRJLNMPSCFM-YDALLXLXSA-M" ] ;
    fhir:format [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C54683" ] ;
    fhir:display [ fhir:v "InChI File (small molecule)" ]         ] )       ]     ] [
    fhir:type [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C45253" ]         ] )       ] ;
    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:format [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C54684" ] ;
    fhir:display [ fhir:v "SMILES" ]         ] )       ]     ] [
    fhir:type [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C54273" ]         ] )       ] ;
    fhir:document [
    fhir:reference [ fhir:v "urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7" ]       ]     ] [
    fhir:type [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C103240" ]         ] )       ] ;
    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://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 ]
      ] [
    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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^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" ]     ]
      ] ) . #

    <urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c> a fhir:SubstanceDefinition ;
      fhir:id [ fhir:v "832f22b4-6f0c-41f8-9b7d-f26f55e9973c"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_832f22b4-6f0c-41f8-9b7d-f26f55e9973c\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 832f22b4-6f0c-41f8-9b7d-f26f55e9973c</b></p><a name=\"832f22b4-6f0c-41f8-9b7d-f26f55e9973c\"> </a><a name=\"hc832f22b4-6f0c-41f8-9b7d-f26f55e9973c\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-polymorphic-form.html\">Polymorphic Form</a></p></div><p><b>identifier</b>: DextroThyroxine</p><blockquote><p><b>structure</b></p><p><b>molecularFormula</b>: C15H10I4NO4.Na.H2O</p><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: ANMYAHDLKVNJJO-CURYUGHLSA-M</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54683}\">InChI File (small molecule)</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: O.[Na+].N[C@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}\">SMILES</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54273}\">Picture</span></p><p><b>document</b>: <a href=\"Bundle-GeneralInformationBundle.html#urn-uuid-0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3\">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</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><span title=\"Codes:{http://fdasis.nlm.nih.gov 0H00N2AHSP}\">0H00N2AHSP</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>DEXTROTHYROXINE SODIUM</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></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "DextroThyroxine" ]
      ] ) ; #
      fhir:structure [
    fhir:molecularFormula [ fhir:v "C15H10I4NO4.Na.H2O" ] ;
        ( fhir:representation [
    fhir:type [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C45253" ]         ] )       ] ;
    fhir:representation [ fhir:v "ANMYAHDLKVNJJO-CURYUGHLSA-M" ] ;
    fhir:format [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C54683" ] ;
    fhir:display [ fhir:v "InChI File (small molecule)" ]         ] )       ]     ] [
    fhir:type [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C45253" ]         ] )       ] ;
    fhir:representation [ fhir:v "O.[Na+].N[C@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O" ] ;
    fhir:format [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C54684" ] ;
    fhir:display [ fhir:v "SMILES" ]         ] )       ]     ] [
    fhir:type [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C54273" ]         ] )       ] ;
    fhir:document [
    fhir:reference [ fhir:v "urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3" ]       ]     ] )
      ] ; #
      fhir:code ( [
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "0H00N2AHSP" ]       ] )     ]
      ] ) ; #
      fhir:name ( [
    fhir:name [ fhir:v "DEXTROTHYROXINE SODIUM" ] ;
    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 ]
      ] ) . #

    <urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b> a fhir:Organization ;
      fhir:id [ fhir:v "e165f057-5eed-4e64-8328-4438fc88fb1b"] ; #
      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_e165f057-5eed-4e64-8328-4438fc88fb1b\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e165f057-5eed-4e64-8328-4438fc88fb1b</b></p><a name=\"e165f057-5eed-4e64-8328-4438fc88fb1b\"> </a><a name=\"hce165f057-5eed-4e64-8328-4438fc88fb1b\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Vandechemie</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>Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium</td></tr></table></div>"^^rdf:XMLLiteral
      ] ; #
      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 "Vandechemie"] ; #
      fhir:contact ( [
    fhir:address [
    fhir:type [ fhir:v "postal" ] ;
    fhir:text [ fhir:v "Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium" ] ;
          ( fhir:line [ fhir:v "Ruzettelaan 39234" ] ) ;
    fhir:city [ fhir:v "Blankenberge" ] ;
    fhir:postalCode [ fhir:v "8370" ] ;
    fhir:country [ fhir:v "BEL" ]     ]
      ] ) . #

    <urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501> a fhir:Organization ;
      fhir:id [ fhir:v "e875ef93-a730-4c44-bead-53663ae7f501"] ; #
      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_e875ef93-a730-4c44-bead-53663ae7f501\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e875ef93-a730-4c44-bead-53663ae7f501</b></p><a name=\"e875ef93-a730-4c44-bead-53663ae7f501\"> </a><a name=\"hce875ef93-a730-4c44-bead-53663ae7f501\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/147275722, FEI/6981397</p><p><b>name</b>: East-West Manufacturing</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>East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States</td></tr></table></div>"^^rdf:XMLLiteral
      ] ; #
      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 "147275722" ]
      ] [
    fhir:type [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134004" ] ;
    fhir:display [ fhir:v "FEI" ]       ] )     ] ;
    fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "6981397" ]
      ] ) ; #
      fhir:name [ fhir:v "East-West Manufacturing"] ; #
      fhir:contact ( [
    fhir:address [
    fhir:type [ fhir:v "postal" ] ;
    fhir:text [ fhir:v "East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States" ] ;
          ( fhir:line [ fhir:v "100 Stillwater Avenue" ] [ fhir:v "Building #2" ] ) ;
    fhir:city [ fhir:v "Bangor" ] ;
    fhir:state [ fhir:v "ME" ] ;
    fhir:postalCode [ fhir:v "04401" ] ;
    fhir:country [ fhir:v "USA" ]     ]
      ] ) . #

    <urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3> a fhir:DocumentReference ;
      fhir:id [ fhir:v "0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DocumentReference_0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference 0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3</b></p><a name=\"0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3\"> </a><a name=\"hc0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-graphic-reference.html\">Graphic Reference</a></p></div><p><b>status</b>: Current</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Data</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td>image/png</td><td>(base64 data - 4,468 base64 chars)</td><td>Monosodium_D-thyroxine_hydrate.png</td></tr></table></blockquote></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:status [ fhir:v "current"] ; #
      fhir:content ( [
    fhir:attachment [
    fhir:contentType [ fhir:v "image/png" ] ;
    fhir:data [ fhir:v " "^^xsd:base64Binary ] ;
    fhir:title [ fhir:v "Monosodium_D-thyroxine_hydrate.png" ]     ]
      ] ) . #

    <urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7> a fhir:DocumentReference ;
      fhir:id [ fhir:v "d94ad7ac-b935-432f-bc68-312b6b8dcca7"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DocumentReference_d94ad7ac-b935-432f-bc68-312b6b8dcca7\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference d94ad7ac-b935-432f-bc68-312b6b8dcca7</b></p><a name=\"d94ad7ac-b935-432f-bc68-312b6b8dcca7\"> </a><a name=\"hcd94ad7ac-b935-432f-bc68-312b6b8dcca7\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-graphic-reference.html\">Graphic Reference</a></p></div><p><b>status</b>: Current</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Data</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td>image/png</td><td>(base64 data - 4,372 base64 chars)</td><td>Levothyroid.png</td></tr></table></blockquote></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:status [ fhir:v "current"] ; #
      fhir:content ( [
    fhir:attachment [
    fhir:contentType [ fhir:v "image/png" ] ;
    fhir:data [ fhir:v " "^^xsd:base64Binary ] ;
    fhir:title [ fhir:v "Levothyroid.png" ]     ]
      ] ) . #

    <urn:uuid:22bd989e-8056-494f-9bc1-195d13428179> a fhir:DocumentReference ;
      fhir:id [ fhir:v "22bd989e-8056-494f-9bc1-195d13428179"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-structure-reference"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-structure-reference>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DocumentReference_22bd989e-8056-494f-9bc1-195d13428179\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference 22bd989e-8056-494f-9bc1-195d13428179</b></p><a name=\"22bd989e-8056-494f-9bc1-195d13428179\"> </a><a name=\"hc22bd989e-8056-494f-9bc1-195d13428179\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-structure-reference.html\">Structure Data Reference</a></p></div><p><b>status</b>: Current</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Data</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td>application/x-mdl-sdfile</td><td>(base64 data - 3,432 base64 chars)</td><td>L-thyroxine-3D-structure-CT1000583834.sdf</td></tr></table></blockquote></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:status [ fhir:v "current"] ; #
      fhir:content ( [
    fhir:attachment [
    fhir:contentType [ fhir:v "application/x-mdl-sdfile" ] ;
    fhir:data [ fhir:v " "^^xsd:base64Binary ] ;
    fhir:title [ fhir:v "L-thyroxine-3D-structure-CT1000583834.sdf" ]     ]
      ] ) . #