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.5.1 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 "SpecificationProductBundle"] ; #
      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:34a0748d-b199-4a2e-a5bc-0f880886fef7" ]
      ] ; #
      fhir:type [ fhir:v "document"] ; #
      fhir:timestamp [ fhir:v "2023-12-15T22:33:13.089Z"^^xsd:dateTime] ; #
      fhir:entry ( [
    fhir:fullUrl [ fhir:v "urn:uuid:d332acdf-4874-407b-9950-528f14c6bea2"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:d332acdf-4874-407b-9950-528f14c6bea2> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a> )
      ] ) . #

    <urn:uuid:d332acdf-4874-407b-9950-528f14c6bea2> a fhir:Composition ;
      fhir:id [ fhir:v "d332acdf-4874-407b-9950-528f14c6bea2"] ; #
      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_d332acdf-4874-407b-9950-528f14c6bea2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition d332acdf-4874-407b-9950-528f14c6bea2</b></p><a name=\"d332acdf-4874-407b-9950-528f14c6bea2\"> </a><a name=\"hcd332acdf-4874-407b-9950-528f14c6bea2\"> </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>: ExampleSpecification</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.5.1}\">m3.2.p.5.1 specification(s)</span></p><p><b>date</b>: 2023-12-15 22:33:13+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 example Drug Product</p></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "ExampleSpecification" ]
      ] ) ; #
      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.5.1" ] ;
    fhir:display [ fhir:v "m3.2.p.5.1 specification(s)" ]     ] )
      ] ; #
      fhir:date [ fhir:v "2023-12-15T22:33:13.089Z"^^xsd:dateTime] ; #
      fhir:author ( [
    fhir:reference [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a" ]
      ] ) ; #
      fhir:title [ fhir:v "Quality Specification for an example Drug Product"] ; #
      fhir:section ( [
    fhir:title [ fhir:v "32P51" ] ;
        ( fhir:entry [
    fhir:reference [ fhir:v "urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7" ]     ] )
      ] ) . #

    <urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7> a fhir:PlanDefinition ;
      fhir:id [ fhir:v "aa514363-d43f-4052-b44e-b67aa4d6dee7"] ; #
      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_aa514363-d43f-4052-b44e-b67aa4d6dee7\"> </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;\">aa514363-d43f-4052-b44e-b67aa4d6dee7</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>ExampleSpecification</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 OXAZEPAM</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>C134021</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Drug Product</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:89676a69-1fe7-422c-ab00-92abe4ef6ea9</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\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 Spectrophotometry Identification:</b> <div><p>Alternate</p>\n</div>\n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Identity - Ferric Chloride:</b> <div><p>Alternate</p>\n</div>\n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Loss on Drying:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Readily Carbonizable Sub:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Residue on ignition (Ash):</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Substances insoluble in sodium carbonate TS:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Impurities - Chloride (Cl):</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Impurities - Sulfate (SO4):</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Elemental Impurities - Limits:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Limit of Free Salicylic Acid:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Organic Volatile Impurities:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Assay Dry Basis:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b> Dissolution - 30 minute:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b>Stage 1 :</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b>Stage 2 :</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b>Stage 3 :</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 "C134011" ] ;
    fhir:display [ fhir:v "Not Approved" ]       ] )     ]
      ] ) ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "ExampleSpecification" ]
      ] ) ; #
      fhir:version [ fhir:v "1.0"] ; #
      fhir:title [ fhir:v "Quality Specification for OXAZEPAM"] ; #
      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 "C134021" ] ;
    fhir:display [ fhir:v "Drug Product" ]     ] )
      ] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:subject [
    a fhir:Reference ;
    fhir:reference [ fhir:v "urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9" ]
      ] ; #
      fhir:date [ fhir:v "2022-12-08"^^xsd:date] ; #
      fhir:goal ( [
    fhir:id [ fhir:v "32649771-1290-4386-9cf7-7a72274f22b4" ] ;
    fhir:description [
    fhir:text [ fhir:v "Average of 10 between 2-3 pH" ]     ] ;
        ( 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:modifierExtension [
            ( fhir:extension [
    fhir:url [ fhir:v "low"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Quantity ;
    fhir:value [ fhir:v "2"^^xsd:decimal ] ;
    fhir:comparator [ fhir:v ">=" ] ;
    fhir:unit [ fhir:v "[pH]" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "[pH]" ]           ]         ] [
    fhir:url [ fhir:v "high"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Quantity ;
    fhir:value [ fhir:v "3"^^xsd:decimal ] ;
    fhir:comparator [ fhir:v "<" ] ;
    fhir:unit [ fhir:v "[pH]" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "[pH]" ]           ]         ] ) ;
    fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"^^xsd:anyURI ]       ] )     ] )
      ] [
    fhir:id [ fhir:v "59a4ca76-858e-4d58-8e5f-88e75f51ec33" ] ;
    fhir:description [
    fhir:text [ fhir:v "Maxima only at the same wavelengths compared to reference standard" ]     ] ;
        ( 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 "Conforms"       ]     ] )
      ] [
    fhir:id [ fhir:v "c40aa176-e6aa-4fe4-869d-6550ee992903" ] ;
    fhir:description [
    fhir:text [ fhir:v "<= 0.5 %" ]     ] ;
        ( 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 0.5 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "b122987d-586c-481b-951c-6202e660158d" ] ;
    fhir:description [
    fhir:text [ fhir:v "Color of solution is clear" ]     ] ;
        ( 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 "Conforms"       ]     ] )
      ] [
    fhir:id [ fhir:v "929747ad-e83a-46f0-bbbc-133ee951e819" ] ;
    fhir:description [
    fhir:text [ fhir:v "<= 0.05 %" ]     ] ;
        ( 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 0.05 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "8d7c85c2-7a4b-432e-ac94-226f296e4fca" ] ;
    fhir:description [
    fhir:text [ fhir:v "No Particulate Matter detected" ]     ] ;
        ( 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 "pass"       ]     ] )
      ] [
    fhir:id [ fhir:v "de4f962a-d486-486d-8d84-f2d1635646b4" ] ;
    fhir:description [
    fhir:text [ fhir:v "<= 0.014 %" ]     ] ;
        ( 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 0.014 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "b46dce64-a009-46cd-ab95-21d1d5b4df77" ] ;
    fhir:description [
    fhir:text [ fhir:v "<= 0.04 %" ]     ] ;
        ( 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 0.04 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "5566f501-37e1-49fb-8783-b20c074ec0c3" ] ;
    fhir:description [
    fhir:text [ fhir:v "<= 0.001 %" ]     ] ;
        ( 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 0.001 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "db19e3ab-e28b-4477-8bd7-2409093ed5a3" ] ;
    fhir:description [
    fhir:text [ fhir:v "Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution" ]     ] ;
        ( 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 "pass"       ]     ] )
      ] [
    fhir:id [ fhir:v "82370588-7aae-4556-9262-a7f50dbd01aa" ] ;
    fhir:description [
    fhir:text [ fhir:v "Ethanol < 0.2%" ]     ] ;
        ( 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:measure [
    fhir:text [ fhir:v "Ethanol" ]       ] ;
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v 0.2 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2" ] ;
    fhir:description [
    fhir:text [ fhir:v "Ethyl Ether < 0.1%" ]     ] ;
        ( 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:target [
    fhir:measure [
    fhir:text [ fhir:v "Ethyl Ether" ]       ] ;
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v 0.1 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "28ad4d5b-d975-4f6e-9792-b3d9cc7ce279" ] ;
    fhir:description [
    fhir:text [ fhir:v "1—propanol < 0.15%" ]     ] ;
        ( 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:target [
    fhir:measure [
    fhir:text [ fhir:v "1—propanol" ]       ] ;
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v 0.15 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "33fa051c-6b3c-4e4d-bd4e-09d39fc253b3" ] ;
    fhir:description [
    fhir:text [ fhir:v "Total < 0.5%" ]     ] ;
        ( 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:target [
    fhir:measure [
    fhir:text [ fhir:v "Total Residual Solvents" ]       ] ;
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v 0.5 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "9100e938-42ff-4004-8473-ed5090d66f3a" ] ;
    fhir:description [
    fhir:text [ fhir:v "99.5 - 100.5 %" ]     ] ;
        ( 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:modifierExtension [
            ( fhir:extension [
    fhir:url [ fhir:v "low"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Quantity ;
    fhir:value [ fhir:v 99.5 ] ;
    fhir:comparator [ fhir:v ">=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]           ]         ] [
    fhir:url [ fhir:v "high"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Quantity ;
    fhir:value [ fhir:v 100.5 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]           ]         ] ) ;
    fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"^^xsd:anyURI ]       ] )     ] )
      ] [
    fhir:id [ fhir:v "af260128-f105-4692-ba40-49f21f12ad46" ] ;
    fhir:description [
    fhir:text [ fhir:v "n=6" ]     ] ;
        ( 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:target [
    fhir:detail [
    a fhir:integer ;
    fhir:v 6       ]     ] )
      ] [
    fhir:id [ fhir:v "31d9dcac-bf72-420b-a415-c924155a83f4" ] ;
    fhir:description [
    fhir:text [ fhir:v "Each unit is NLT Q + 5%" ]     ] ;
        ( 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:target [
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v "85"^^xsd:decimal ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "47c0d685-0b23-4637-9af8-a554e4fad7ec" ] ;
    fhir:description [
    fhir:text [ fhir:v "n=6" ]     ] ;
        ( 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:target [
    fhir:detail [
    a fhir:integer ;
    fhir:v 6       ]     ] )
      ] [
    fhir:id [ fhir:v "14d3dee8-e024-4367-b0a2-a2a809303ee0" ] ;
    fhir:description [
    fhir:text [ fhir:v "Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q - 15%" ]     ] ;
        ( 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:target [
    fhir:measure [
    fhir:text [ fhir:v "Average of 12 units" ]       ] ;
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v "80"^^xsd:decimal ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] [
    fhir:measure [
    fhir:text [ fhir:v "unit" ]       ] ;
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v "65"^^xsd:decimal ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "15309a78-92a9-4cf9-aee1-452d6d2f7a91" ] ;
    fhir:description [
    fhir:text [ fhir:v "Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q - 15%, no unit is less than Q - 25%" ]     ] ;
        ( 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:target [
    fhir:measure [
    fhir:text [ fhir:v "Average of 24 units" ]       ] ;
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v "80"^^xsd:decimal ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%" ]       ]     ] [
    fhir:measure [
    fhir:text [ fhir:v "units less than Q - 15%" ]       ] ;
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v "2"^^xsd:decimal ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "Amb a 1 units" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "[Amb'a'1'U]" ]       ]     ] [
    fhir:measure [
    fhir:text [ fhir:v "units less than Q - 25%" ]       ] ;
    fhir:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v "0"^^xsd:decimal ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "Amb a 1 units" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "[Amb'a'1'U]" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "666ace1e-bd29-4263-9ae2-2391106326bb" ] ;
    fhir:description [
    fhir:text [ fhir:v "n=12" ]     ] ;
        ( 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:target [
    fhir:detail [
    a fhir:integer ;
    fhir:v 12       ]     ] )
      ] ) ; #
      fhir:action ( [
    fhir:id [ fhir:v "2047a6b6-e3fc-4071-8989-526297579091" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Spectrophotometry Identification" ] ;
    fhir:description [ fhir:v "Alternate" ] ;
    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 "Spectrophotometry" ]     ] ;
        ( 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 "C138993" ] ;
    fhir:display [ fhir:v "Identification" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "USP <197>" ]     ] ) ;
        ( fhir:goalId [ fhir:v "32649771-1290-4386-9cf7-7a72274f22b4" ] ) ;
        ( fhir:relatedAction [
    fhir:targetId [ fhir:v "84d64dd8-b799-418a-a713-a854c4d3c2b9" ] ;
    fhir:relationship [ fhir:v "concurrent" ]     ] )
      ] [
    fhir:id [ fhir:v "84d64dd8-b799-418a-a713-a854c4d3c2b9" ] ;
    fhir:linkId [ fhir:v "2047a6b6-e3fc-4071-8989-526297579091" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Identity - Ferric Chloride" ] ;
    fhir:description [ fhir:v "Alternate" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C96103" ] ;
    fhir:display [ fhir:v "Proprietary" ]       ] ) ;
    fhir:text [ fhir:v "HPLC" ]     ] ;
        ( 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 "C138993" ] ;
    fhir:display [ fhir:v "Identification" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "EX-TEST-01" ]     ] ) ;
        ( fhir:goalId [ fhir:v "59a4ca76-858e-4d58-8e5f-88e75f51ec33" ] ) ;
        ( fhir:relatedAction [
    fhir:targetId [ fhir:v "2047a6b6-e3fc-4071-8989-526297579091" ] ;
    fhir:relationship [ fhir:v "concurrent" ]     ] )
      ] [
    fhir:id [ fhir:v "838e66ce-f4b0-47a5-8ea0-aa7882a84303" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Loss on Drying" ] ;
    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 "C134255" ] ;
    fhir:display [ fhir:v "Loss on Drying" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "USP <731>" ]     ] ) ;
        ( fhir:goalId [ fhir:v "c40aa176-e6aa-4fe4-869d-6550ee992903" ] )
      ] [
    fhir:id [ fhir:v "3510686b-fb93-4980-a41c-0a3754be7f37" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Readily Carbonizable Sub" ] ;
    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 "C205026" ] ;
    fhir:display [ fhir:v "Organoleptic" ]       ] )     ] [
          ( 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 "2"^^xsd:positiveInteger         ]       ] ) ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134262" ] ;
    fhir:display [ fhir:v "Color of Solution" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "USP <271>" ]     ] ) ;
        ( fhir:goalId [ fhir:v "b122987d-586c-481b-951c-6202e660158d" ] )
      ] [
    fhir:id [ fhir:v "b2e18cc4-f494-4ef0-be34-810d8d4b439b" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Residue on ignition (Ash)" ] ;
    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 "C134276" ] ;
    fhir:display [ fhir:v "Residue on Ignition" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "USP <281>" ]     ] ) ;
        ( fhir:goalId [ fhir:v "929747ad-e83a-46f0-bbbc-133ee951e819" ] )
      ] [
    fhir:id [ fhir:v "d315a1c3-dd93-498d-8ae3-dc0d4b3bec75" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Substances insoluble in sodium carbonate TS" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C96103" ] ;
    fhir:display [ fhir:v "Proprietary" ]       ] ) ;
    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 "C193381" ] ;
    fhir:display [ fhir:v "Foreign and Particulate Matter" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "EX-TEST-02" ]     ] ) ;
        ( fhir:goalId [ fhir:v "8d7c85c2-7a4b-432e-ac94-226f296e4fca" ] )
      ] [
    fhir:id [ fhir:v "6ec15bbc-a78a-4351-9ad8-fcf97e839ab9" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Impurities - Chloride (Cl)" ] ;
    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 "FTIR" ]     ] ;
        ( 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 "C204971" ] ;
    fhir:display [ fhir:v "Impurity" ]       ] )     ] [
          ( 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 "2"^^xsd:positiveInteger         ]       ] ) ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C205039" ] ;
    fhir:display [ fhir:v "Specified Identified Impurity" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "USP <221>" ]     ] ) ;
        ( fhir:goalId [ fhir:v "de4f962a-d486-486d-8d84-f2d1635646b4" ] )
      ] [
    fhir:id [ fhir:v "fa31b425-896c-4b25-b693-ccdd14e0c8ee" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Impurities - Sulfate (SO4)" ] ;
    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 "FTIR" ]     ] ;
        ( 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 "C204971" ] ;
    fhir:display [ fhir:v "Impurity" ]       ] )     ] [
          ( 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 "2"^^xsd:positiveInteger         ]       ] ) ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C205039" ] ;
    fhir:display [ fhir:v "Specified Identified Impurity" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "USP <221>" ]     ] ) ;
        ( fhir:goalId [ fhir:v "b46dce64-a009-46cd-ab95-21d1d5b4df77" ] )
      ] [
    fhir:id [ fhir:v "cef5aa1a-8770-4f78-9bc3-da9f18b77e5c" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Elemental Impurities - Limits" ] ;
    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 "UV" ]     ] ;
        ( 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 "C204971" ] ;
    fhir:display [ fhir:v "Impurity" ]       ] )     ] [
          ( 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 "2"^^xsd:positiveInteger         ]       ] ) ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C205014" ] ;
    fhir:display [ fhir:v "Elemental Impurity" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "USP <231>" ]     ] ) ;
        ( fhir:goalId [ fhir:v "5566f501-37e1-49fb-8783-b20c074ec0c3" ] )
      ] [
    fhir:id [ fhir:v "d5871ee2-8b06-414c-91b4-4b30f5881c8a" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Limit of Free Salicylic Acid" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C96103" ] ;
    fhir:display [ fhir:v "Proprietary" ]       ] ) ;
    fhir:text [ fhir:v "Titration" ]     ] ;
        ( 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 "C204971" ] ;
    fhir:display [ fhir:v "Impurity" ]       ] )     ] [
          ( 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 "2"^^xsd:positiveInteger         ]       ] ) ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134254" ] ;
    fhir:display [ fhir:v "Impurities/Degradation Products/Related Substances" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "EX-TEST-03" ]     ] ) ;
        ( fhir:goalId [ fhir:v "db19e3ab-e28b-4477-8bd7-2409093ed5a3" ] )
      ] [
    fhir:id [ fhir:v "e192fc72-c4b1-419f-8098-6f65037a3962" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Organic Volatile Impurities" ] ;
    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 "C204971" ] ;
    fhir:display [ fhir:v "Impurity" ]       ] )     ] [
          ( 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 "2"^^xsd:positiveInteger         ]       ] ) ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C134002" ] ;
    fhir:display [ fhir:v "Residual Solvent" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "USP <467>" ]     ] ) ;
        ( fhir:goalId [ fhir:v "82370588-7aae-4556-9262-a7f50dbd01aa" ] [ fhir:v "cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2" ] [ fhir:v "28ad4d5b-d975-4f6e-9792-b3d9cc7ce279" ] [ fhir:v "33fa051c-6b3c-4e4d-bd4e-09d39fc253b3" ] )
      ] [
    fhir:id [ fhir:v "b7e88ea0-3c61-49db-86ec-8d01f8b7667b" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Assay Dry Basis" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C96103" ] ;
    fhir:display [ fhir:v "Proprietary" ]       ] ) ;
    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 "C60819" ] ;
    fhir:display [ fhir:v "Assay" ]       ] )     ] [
          ( 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 "2"^^xsd:positiveInteger         ]       ] ) ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C204845" ] ;
    fhir:display [ fhir:v "Active Ingredient Content" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "EX-TEST-04" ]     ] ) ;
        ( fhir:goalId [ fhir:v "9100e938-42ff-4004-8473-ed5090d66f3a" ] )
      ] [
    fhir:id [ fhir:v "6d1ba5a8-6590-496a-ad6b-ca68cfda2878" ] ;
    fhir:title [ fhir:v "Dissolution - 30 minute" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C96103" ] ;
    fhir:display [ fhir:v "Proprietary" ]       ] ) ;
    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 "C134253" ] ;
    fhir:display [ fhir:v "Dissolution" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "EX-TEST-05" ]     ] ) ;
        ( fhir:action [
    fhir:linkId [ fhir:v "6d1ba5a8-6590-496a-ad6b-ca68cfda2878" ] ;
    fhir:prefix [ fhir:v "Stage 1" ] ;
          ( fhir:goalId [ fhir:v "af260128-f105-4692-ba40-49f21f12ad46" ] [ fhir:v "31d9dcac-bf72-420b-a415-c924155a83f4" ] )     ] [
    fhir:linkId [ fhir:v "6d1ba5a8-6590-496a-ad6b-ca68cfda2878" ] ;
    fhir:prefix [ fhir:v "Stage 2" ] ;
          ( fhir:goalId [ fhir:v "47c0d685-0b23-4637-9af8-a554e4fad7ec" ] [ fhir:v "14d3dee8-e024-4367-b0a2-a2a809303ee0" ] )     ] [
    fhir:linkId [ fhir:v "6d1ba5a8-6590-496a-ad6b-ca68cfda2878" ] ;
    fhir:prefix [ fhir:v "Stage 3" ] ;
          ( fhir:goalId [ fhir:v "15309a78-92a9-4cf9-aee1-452d6d2f7a91" ] [ fhir:v "666ace1e-bd29-4263-9ae2-2391106326bb" ] )     ] )
      ] ) . #

    <urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9> a fhir:MedicinalProductDefinition ;
      fhir:id [ fhir:v "89676a69-1fe7-422c-ab00-92abe4ef6ea9"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition 89676a69-1fe7-422c-ab00-92abe4ef6ea9</b></p><a name=\"89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><a name=\"hc89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </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-handle.html\">Drug Product Handle</a></p></div><p><b>identifier</b>: Example2BeadDrug</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C25158}\">CAPSULE</span></p><p><b>route</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}\">ORAL</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg</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>: OXAZEPAM</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>: 30mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">OXAZEPAM</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: PROPRANOLOL HYDROCHLORIDE</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>: 60mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">PROPRANOLOL HYDROCHLORIDE</span></p></blockquote></blockquote></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "Example2BeadDrug" ]
      ] ) ; #
      fhir:combinedPharmaceuticalDoseForm [
        ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C25158" ] ;
    fhir:display [ fhir:v "CAPSULE" ]     ] )
      ] ; #
      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:name ( [
    fhir:productName [ fhir:v "OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg" ] ;
    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 "OXAZEPAM" ] ;
    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 "30mg" ] ;
    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 "OXAZEPAM" ]       ]     ] [
    fhir:part [ fhir:v "PROPRANOLOL HYDROCHLORIDE" ] ;
    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 "60mg" ] ;
    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 "PROPRANOLOL HYDROCHLORIDE" ]       ]     ] )
      ] ) . #

    <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" ]     ]
      ] ) . #