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.4.1 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 "SpecificationSubstanceBundle"] ; #
      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:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "urn:uuid:3e9cc7a1-e157-4b46-980a-33a8e50dcf65" ]
      ] ; #
      fhir:type [ fhir:v "document"] ; #
      fhir:timestamp [ fhir:v "2023-12-15T22:36:51.299Z"^^xsd:dateTime] ; #
      fhir:entry ( [
    fhir:fullUrl [ fhir:v "urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049> )
      ] ) . #

    <urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f> a fhir:Composition ;
      fhir:id [ fhir:v "55d92f43-e328-4011-bbcf-744e3afd954f"] ; #
      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_55d92f43-e328-4011-bbcf-744e3afd954f\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 55d92f43-e328-4011-bbcf-744e3afd954f</b></p><a name=\"55d92f43-e328-4011-bbcf-744e3afd954f\"> </a><a name=\"hc55d92f43-e328-4011-bbcf-744e3afd954f\"> </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-sp4151.html\">eCTD Specification</a></p></div><p><b>identifier</b>: ExampleSpecification2</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.s.4.1}\">m3.2.s.4.1 specification</span></p><p><b>date</b>: 2023-12-15 22:36:51+0000</p><p><b>author</b>: <a href=\"Bundle-BatchFormulaBundle.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><p><b>title</b>: Quality Specification for an API</p></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "ExampleSpecification2" ]
      ] ) ; #
      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.4.1" ] ;
    fhir:display [ fhir:v "m3.2.s.4.1 specification" ]     ] )
      ] ; #
      fhir:date [ fhir:v "2023-12-15T22:36:51.299Z"^^xsd:dateTime] ; #
      fhir:author ( [
    fhir:reference [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a" ]
      ] ) ; #
      fhir:title [ fhir:v "Quality Specification for an API"] ; #
      fhir:section ( [
    fhir:title [ fhir:v "32S41" ] ;
        ( fhir:entry [
    fhir:reference [ fhir:v "urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93" ]     ] )
      ] ) . #

    <urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93> a fhir:PlanDefinition ;
      fhir:id [ fhir:v "cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"] ; #
      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_cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93\"> </a>\n<div>\n    <table class=\"grid dict\">\n        \n        <tr>\n            <th scope=\"row\"><b>Id: </b></th>\n            <td style=\"padding-left: 4px;\">cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93</td>\n        </tr>\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Version: </b></th>\n            <td style=\"padding-left: 4px;\">1.0</td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\">\n                <b>\n                    \n                        \n                    \n                </b>\n            </th>\n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <span>ExampleSpecification2</span>\n                </p>\n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Title: </b></th>\n            <td style=\"padding-left: 4px;\">Quality Specification for an API</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Type: </b></th>\n            <td style=\"padding-left: 4px;\">\n                \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>workflow-definition</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Workflow Definition</span>\n                        </p>\n                        \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>C134022</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Drug Substance</span>\n                        </p>\n                        \n                    \n                \n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Subject: </b></th>\n            \n            \n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <b>reference: </b> <span>urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf</span>\n                </p>\n                \n                \n                \n            </td>\n            \n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Date: </b></th>\n            <td style=\"padding-left: 4px;\">2022-12-08</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Approval Date: </b></th>\n            <td style=\"padding-left: 4px;\">2022-12-08</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Actions: </b></th>\n            <td style=\"padding-left: 4px;\">\n                <table class=\"grid-dict\">\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Microbiological Examination of Nonsterile Products:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Staphylococcus aureus:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Pseudomonas aeruginosa:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Bacillus subtilis:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Total Aerobic Microbial Count (TAMC):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Total Yeasts and Molds Count (TYMC):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                </table>\n            </td>\n        </tr>\n        \n    </table>\n</div>\n</div>"^^rdf:XMLLiteral
      ] ; #
      fhir:extension ( [
    fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:CodeableConcept ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134010" ] ;
    fhir:display [ fhir:v "Tentatively Approved" ]       ] )     ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:markdown ;
    fhir:v "This API is is currently characterized through a standard battery of physicochemical characterzation tests."     ]
      ] ) ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "ExampleSpecification2" ]
      ] ) ; #
      fhir:version [ fhir:v "1.0"] ; #
      fhir:title [ fhir:v "Quality Specification for an API"] ; #
      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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134022" ] ;
    fhir:display [ fhir:v "Drug Substance" ]     ] )
      ] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:subject [
    a fhir:Reference ;
    fhir:reference [ fhir:v "urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf" ]
      ] ; #
      fhir:date [ fhir:v "2022-12-08"^^xsd:date] ; #
      fhir:approvalDate [ fhir:v "2022-12-08"^^xsd:date] ; #
      fhir:goal ( [
    fhir:id [ fhir:v "b304ed45-5295-4082-9827-f20e1ff0d1d3" ] ;
    fhir:description [
    fhir:text [ fhir:v "Negative" ]     ] ;
        ( fhir:addresses [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134029" ] ;
    fhir:display [ fhir:v "Release" ]       ] )     ] [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134030" ] ;
    fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
        ( fhir:target [
    fhir:detail [
    a fhir:string ;
    fhir:v "Negative"       ]     ] )
      ] [
    fhir:id [ fhir:v "d4e38c52-30f6-4bb7-ab84-99439a7266ce" ] ;
    fhir:description [
    fhir:text [ fhir:v "Negative" ]     ] ;
        ( fhir:addresses [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134029" ] ;
    fhir:display [ fhir:v "Release" ]       ] )     ] [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134030" ] ;
    fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
        ( fhir:target [
    fhir:detail [
    a fhir:string ;
    fhir:v "Negative"       ]     ] )
      ] [
    fhir:id [ fhir:v "2abf1f19-e1b1-42e4-b943-79f5fa1642fe" ] ;
    fhir:description [
    fhir:text [ fhir:v "Negative" ]     ] ;
        ( fhir:addresses [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134029" ] ;
    fhir:display [ fhir:v "Release" ]       ] )     ] [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134030" ] ;
    fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
        ( fhir:target [
    fhir:detail [
    a fhir:string ;
    fhir:v "Negative"       ]     ] )
      ] [
    fhir:id [ fhir:v "c0ed4a79-8f40-4d26-8845-4cea166fb627" ] ;
    fhir:description [
    fhir:text [ fhir:v "NMT 10 colony-forming units" ]     ] ;
        ( fhir:addresses [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134029" ] ;
    fhir:display [ fhir:v "Release" ]       ] )     ] [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134030" ] ;
    fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
        ( fhir:target [
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v "10"^^xsd:decimal ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "colony forming unit" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "[CFU]" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "442983b5-bbc3-4534-9f1b-5ae5e4c531c1" ] ;
    fhir:description [
    fhir:text [ fhir:v "NMT 100 colony-forming units" ]     ] ;
        ( fhir:addresses [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134029" ] ;
    fhir:display [ fhir:v "Release" ]       ] )     ] [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134030" ] ;
    fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
        ( fhir:target [
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v "100"^^xsd:decimal ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "colony forming unit" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "[CFU]" ]       ]     ] )
      ] ) ; #
      fhir:action ( [
    fhir:id [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Microbiological Examination of Nonsterile Products" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^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 [
    a fhir:positiveInt ;
    fhir:v "1"^^xsd:positiveInteger         ]       ] ) ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134256" ] ;
    fhir:display [ fhir:v "Microbial Limits" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "USP <61>" ]     ] ) ;
        ( fhir:action [
    fhir:linkId [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ;
    fhir:title [ fhir:v "Staphylococcus aureus" ] ;
          ( fhir:goalId [ fhir:v "b304ed45-5295-4082-9827-f20e1ff0d1d3" ] )     ] [
    fhir:linkId [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ;
    fhir:title [ fhir:v "Pseudomonas aeruginosa" ] ;
          ( fhir:goalId [ fhir:v "d4e38c52-30f6-4bb7-ab84-99439a7266ce" ] )     ] [
    fhir:linkId [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ;
    fhir:title [ fhir:v "Bacillus subtilis" ] ;
          ( fhir:goalId [ fhir:v "2abf1f19-e1b1-42e4-b943-79f5fa1642fe" ] )     ] [
    fhir:linkId [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ;
    fhir:title [ fhir:v "Total Aerobic Microbial Count (TAMC)" ] ;
          ( fhir:goalId [ fhir:v "c0ed4a79-8f40-4d26-8845-4cea166fb627" ] )     ] [
    fhir:linkId [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ;
    fhir:title [ fhir:v "Total Yeasts and Molds Count (TYMC)" ] ;
          ( fhir:goalId [ fhir:v "442983b5-bbc3-4534-9f1b-5ae5e4c531c1" ] )     ] )
      ] ) . #

    <urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf> a fhir:SubstanceDefinition ;
      fhir:id [ fhir:v "580c28ac-1a2c-49fa-9be3-de997da5edcf"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 580c28ac-1a2c-49fa-9be3-de997da5edcf</b></p><a name=\"580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </a><a name=\"hc580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </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-routine-drug-substance.html\">Drug Substance Handle</a></p></div><p><b>identifier</b>: P-Isobutylhydratropic Acid</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><p><b>manufacturer</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</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><span title=\"Codes:{http://fdasis.nlm.nih.gov WK2XYI10QM}\">WK2XYI10QM</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>IBUPROFENPIRIN</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 "P-Isobutylhydratropic Acid" ]
      ] ) ; #
      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:grade ( [
        ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134006" ] ;
    fhir:display [ fhir:v "USP-NF" ]     ] )
      ] ) ; #
      fhir:manufacturer ( [
    fhir:reference [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5" ]
      ] ) ; #
      fhir:supplier ( [
    fhir:reference [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" ]
      ] ) ; #
      fhir:code ( [
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "WK2XYI10QM" ]       ] )     ]
      ] ) ; #
      fhir:name ( [
    fhir:name [ fhir:v "IBUPROFENPIRIN" ] ;
    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: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-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_4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </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>: 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>"^^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 "Wunderwerke"] ; #
      fhir:contact ( [
    fhir:address [
    fhir:type [ fhir:v "postal" ] ;
    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" ]     ]
      ] ) . #

    <urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5> a fhir:Organization ;
      fhir:id [ fhir:v "e99bddfa-c1b5-435b-bbe8-24816b4e23e5"] ; #
      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_e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5</b></p><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"hce99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </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, FEI/6981397</p><p><b>name</b>: Vidinaid</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>Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, 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: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 "Vidinaid"] ; #
      fhir:contact ( [
    fhir:address [
    fhir:type [ fhir:v "postal" ] ;
    fhir:text [ fhir:v "Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA" ] ;
          ( 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:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049> a fhir:Organization ;
      fhir:id [ fhir:v "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"] ; #
      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_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</b></p><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </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/173265332</p><p><b>name</b>: Mega Chem Supply</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>Mega Chem Supply, 350 W Main Street, Rochester, 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 "173265332" ]
      ] ) ; #
      fhir:name [ fhir:v "Mega Chem Supply"] ; #
      fhir:contact ( [
    fhir:address [
    fhir:type [ fhir:v "postal" ] ;
    fhir:text [ fhir:v "Mega Chem Supply, 350 W Main Street, Rochester, NY, United States" ] ;
          ( fhir:line [ fhir:v "350 W Main Street" ] ) ;
    fhir:city [ fhir:v "Rochester" ] ;
    fhir:state [ fhir:v "NY" ] ;
    fhir:postalCode [ fhir:v "14608" ] ;
    fhir:country [ fhir:v "USA" ]     ]
      ] ) . #