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.P.5.5 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 "CharacterisationImpuritiesProductBundle"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p55"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p55>     ] )
      ] ; #
      fhir:identifier [
    fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "urn:uuid:2b738e27-de1f-4f63-8d91-c8860089d2a1" ]
      ] ; #
      fhir:type [ fhir:v "document"] ; #
      fhir:timestamp [ fhir:v "2024-04-24T01:12:07.108Z"^^xsd:dateTime] ; #
      fhir:entry ( [
    fhir:fullUrl [ fhir:v "urn:uuid:8a07e353-9cf6-4f27-8a30-2c2d4f439847"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:8a07e353-9cf6-4f27-8a30-2c2d4f439847> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989> )
      ] ) . #

    <urn:uuid:8a07e353-9cf6-4f27-8a30-2c2d4f439847> a fhir:Composition ;
      fhir:id [ fhir:v "8a07e353-9cf6-4f27-8a30-2c2d4f439847"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p55"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p55>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 8a07e353-9cf6-4f27-8a30-2c2d4f439847</b></p><a name=\"8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </a><a name=\"hc8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </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-32p55.html\">eCTD Product Characterisation of Impurities</a></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.5.5}\">m3.2.p.5.5 characterisation of impurities</span></p><p><b>date</b>: 2024-04-24 01:12:07+0000</p><p><b>author</b>: <a href=\"Bundle-CharacterisationImpuritiesProductBundle.html#urn-uuid-98effc99-db2b-428d-89aa-0ce426e02788\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></p><p><b>title</b>: Product Characterisation of Impurities</p></div>"^^rdf:XMLLiteral
      ] ; #
      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.p.5.5" ] ;
    fhir:display [ fhir:v "m3.2.p.5.5 characterisation of impurities" ]     ] )
      ] ; #
      fhir:date [ fhir:v "2024-04-24T01:12:07.108Z"^^xsd:dateTime] ; #
      fhir:author ( [
    fhir:reference [ fhir:v "urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788" ]
      ] ) ; #
      fhir:title [ fhir:v "Product Characterisation of Impurities"] ; #
      fhir:section ( [
    fhir:title [ fhir:v "Impurities for TabletCoatedBeadsCoatedAll" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/ICHContextOfUse"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "ich_3.2.p.5.5" ] ;
    fhir:display [ fhir:v "m3.2.p.5.5 characterisation of impurities" ]       ] )     ] ;
        ( fhir:entry [
    fhir:reference [ fhir:v "urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502" ]     ] )
      ] ) . #

    <urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502> a fhir:MedicinalProductDefinition ;
      fhir:id [ fhir:v "ddd3abad-347c-4d2f-95f3-dd804e250502"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition ddd3abad-347c-4d2f-95f3-dd804e250502</b></p><a name=\"ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><a name=\"hcddd3abad-347c-4d2f-95f3-dd804e250502\"> </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-product-with-impurities.html\">Drug Product Impurities</a></p></div><p><b>identifier</b>: TabletCoatedBeadsCoatedAll</p><p><b>description</b>: </p><div><p>A drug product composed of one type of bead with two coatings inside a coated tablet</p>\n</div><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42964}\">TABLET, MULTILAYER</span></p><p><b>route</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}\">ORAL</span></p><h3>Impurities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-CharacterisationImpuritiesProductBundle.html#urn-uuid-58ae52aa-c81e-415a-8791-e67a3195290d\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-CharacterisationImpuritiesProductBundle.html#urn-uuid-ffa30c0b-8031-436a-87f1-635b3bbe5989\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: LEVOTHYROXINE SODIUM ANHYDROUS 125mg</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}\">Non-Proprietary</span></p><blockquote><p><b>part</b></p><p><b>part</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 125mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">LEVOTHYROXINE SODIUM ANHYDROUS</span></p></blockquote></blockquote></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "TabletCoatedBeadsCoatedAll" ]
      ] ) ; #
      fhir:description [ fhir:v "A drug product composed of one type of bead with two coatings inside a coated tablet"] ; #
      fhir:combinedPharmaceuticalDoseForm [
        ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C42964" ] ;
    fhir:display [ fhir:v "TABLET, MULTILAYER" ]     ] )
      ] ; #
      fhir:route ( [
        ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C38288" ] ;
    fhir:display [ fhir:v "ORAL" ]     ] )
      ] ) ; #
      fhir:impurity ( [
    fhir:reference [
    fhir:reference [ fhir:v "urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d" ]     ]
      ] [
    fhir:reference [
    fhir:reference [ fhir:v "urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989" ]     ]
      ] ) ; #
      fhir:name ( [
    fhir:productName [ fhir:v "LEVOTHYROXINE SODIUM ANHYDROUS 125mg" ] ;
    fhir:type [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C96971" ] ;
    fhir:display [ fhir:v "Nonproprietary Name" ]       ] ) ;
    fhir:text [ fhir:v "Non-Proprietary" ]     ] ;
        ( fhir:part [
    fhir:part [ fhir:v "LEVOTHYROXINE SODIUM ANHYDROUS" ] ;
    fhir:type [
            ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "SCI" ]         ] )       ]     ] [
    fhir:part [ fhir:v "125mg" ] ;
    fhir:type [
            ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "STR" ]         ] ) ;
    fhir:text [ fhir:v "LEVOTHYROXINE SODIUM ANHYDROUS" ]       ]     ] )
      ] ) . #

    <urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788> a fhir:Organization ;
      fhir:id [ fhir:v "98effc99-db2b-428d-89aa-0ce426e02788"] ; #
      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_98effc99-db2b-428d-89aa-0ce426e02788\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 98effc99-db2b-428d-89aa-0ce426e02788</b></p><a name=\"98effc99-db2b-428d-89aa-0ce426e02788\"> </a><a name=\"hc98effc99-db2b-428d-89aa-0ce426e02788\"> </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>: connectathon_Site</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>connectathon_Site, Restful Rd, Danbury, CT, USA</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 "connectathon_Site"] ; #
      fhir:contact ( [
    fhir:address [
    fhir:type [ fhir:v "postal" ] ;
    fhir:text [ fhir:v "connectathon_Site, Restful Rd, Danbury, CT, USA" ] ;
          ( fhir:line [ fhir:v "Restful Rd" ] ) ;
    fhir:city [ fhir:v "Danbury" ] ;
    fhir:state [ fhir:v "CT" ] ;
    fhir:postalCode [ fhir:v "06811" ] ;
    fhir:country [ fhir:v "USA" ]     ]
      ] ) . #

    <urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d> a fhir:SubstanceDefinition ;
      fhir:id [ fhir:v "58ae52aa-c81e-415a-8791-e67a3195290d"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 58ae52aa-c81e-415a-8791-e67a3195290d</b></p><a name=\"58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><a name=\"hc58ae52aa-c81e-415a-8791-e67a3195290d\"> </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-product-substance-impurity.html\">Drug Substance Impurity</a></p></div><p><b>identifier</b>: DCM</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176815}\">Residual Solvent</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title=\"Codes:\">Leftover Solvent</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>: YMWUJEATGCHHMB-UHFFFAOYSA-N</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>: ClCCl</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}\">SMILES</span></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 588X2YUY0A}\">588X2YUY0A</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>DICHLOROMETHANE</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C97054}\">Generic Name</span></td><td>true</td></tr></table></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "DCM" ]
      ] ) ; #
      fhir:classification ( [
        ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C176815" ] ;
    fhir:display [ fhir:v "Residual Solvent" ]     ] )
      ] ) ; #
      fhir:structure [
        ( fhir:technique [
    fhir:text [ fhir:v "Leftover Solvent" ]     ] ) ;
        ( 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 "YMWUJEATGCHHMB-UHFFFAOYSA-N" ] ;
    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 "ClCCl" ] ;
    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:code ( [
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "588X2YUY0A" ]       ] )     ]
      ] ) ; #
      fhir:name ( [
    fhir:name [ fhir:v "DICHLOROMETHANE" ] ;
    fhir:type [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C97054" ] ;
    fhir:display [ fhir:v "Generic Name" ]       ] )     ] ;
    fhir:preferred [ fhir:v true ]
      ] ) . #

    <urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989> a fhir:SubstanceDefinition ;
      fhir:id [ fhir:v "ffa30c0b-8031-436a-87f1-635b3bbe5989"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition ffa30c0b-8031-436a-87f1-635b3bbe5989</b></p><a name=\"ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><a name=\"hcffa30c0b-8031-436a-87f1-635b3bbe5989\"> </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-product-substance-impurity.html\">Drug Substance Impurity</a></p></div><p><b>identifier</b>: hydroxyApatite</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176816}\">Degradation Product</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title=\"Codes:\">formed from dicalcium phosphate degradation</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>: XZFUZCHOJLQYHV-UHFFFAOYSA-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>: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([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><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 91D9GV0Z28}\">91D9GV0Z28</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>TRIBASIC CALCIUM PHOSPHATE</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 "hydroxyApatite" ]
      ] ) ; #
      fhir:classification ( [
        ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C176816" ] ;
    fhir:display [ fhir:v "Degradation Product" ]     ] )
      ] ) ; #
      fhir:structure [
        ( fhir:technique [
    fhir:text [ fhir:v "formed from dicalcium phosphate degradation" ]     ] ) ;
        ( 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 "XZFUZCHOJLQYHV-UHFFFAOYSA-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 "[OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([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:code ( [
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "91D9GV0Z28" ]       ] )     ]
      ] ) ; #
      fhir:name ( [
    fhir:name [ fhir:v "TRIBASIC CALCIUM PHOSPHATE" ] ;
    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 ]
      ] ) . #