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.4 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 "SpecificationExcipientBundle"] ; #
      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:813b4312-8b6d-42cc-9b8c-8bb6463388cc" ]
      ] ; #
      fhir:type [ fhir:v "document"] ; #
      fhir:timestamp [ fhir:v "2024-01-01T19:42:35.255Z"^^xsd:dateTime] ; #
      fhir:entry ( [
    fhir:fullUrl [ fhir:v "urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a> )
      ] ) . #

    <urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4> a fhir:Composition ;
      fhir:id [ fhir:v "4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"] ; #
      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_4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 4bd1ed57-852b-42be-a9b0-355f8a2aa7d4</b></p><a name=\"4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><a name=\"hc4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </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>: CochinealSpecificationComposition</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.4}\">m3.2.p.4 control of excipients</span></p><p><b>date</b>: 2024-01-01 19:42:35+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>: Cochineal specification Composition Example</p></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "CochinealSpecificationComposition" ]
      ] ) ; #
      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.4" ] ;
    fhir:display [ fhir:v "m3.2.p.4 control of excipients" ]     ] )
      ] ; #
      fhir:date [ fhir:v "2024-01-01T19:42:35.254Z"^^xsd:dateTime] ; #
      fhir:author ( [
    fhir:reference [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a" ]
      ] ) ; #
      fhir:title [ fhir:v "Cochineal specification Composition Example"] ; #
      fhir:section ( [
    fhir:title [ fhir:v "32P40" ] ;
        ( fhir:entry [
    fhir:reference [ fhir:v "urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e" ]     ] )
      ] ) . #

    <urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e> a fhir:PlanDefinition ;
      fhir:id [ fhir:v "37bf5cc0-33bf-478b-b84e-ccb35143ef6e"] ; #
      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_37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </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;\">37bf5cc0-33bf-478b-b84e-ccb35143ef6e</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>CochinealSpecification</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;\">Cochineal specification Example</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>C133931</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</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:278736ef-2ddf-49e4-895c-3a9f34db36cf</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;\">2023-12-01</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 Appearance:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Identification:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage pH:</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:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Impurities:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Unidentified Impurities:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        <b>Then:</b> <i>Additional sub-actions not displayed</i>\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 "C48660" ] ;
    fhir:display [ fhir:v "Not Applicable" ]       ] )     ]
      ] ) ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "CochinealSpecification" ]
      ] ) ; #
      fhir:version [ fhir:v "1.0"] ; #
      fhir:title [ fhir:v "Cochineal specification Example"] ; #
      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 "C133931" ] ;
    fhir:display [ fhir:v "Raw Materials/Excipients/Intermediates/Reagents" ]     ] )
      ] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:subject [
    a fhir:Reference ;
    fhir:reference [ fhir:v "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf" ]
      ] ; #
      fhir:date [ fhir:v "2023-12-01"^^xsd:date] ; #
      fhir:goal ( [
    fhir:id [ fhir:v "e900181a-876c-4ed6-ac96-d5a73c3d6767" ] ;
    fhir:description [
    fhir:text [ fhir:v "White Solid" ]     ] ;
        ( 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 "White solid"       ]     ] )
      ] [
    fhir:id [ fhir:v "21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c" ] ;
    fhir:description [
    fhir:text [ fhir:v "IR spectrum conforms 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 "IR spectrum conforms to reference standard"       ]     ] )
      ] [
    fhir:id [ fhir:v "1f476689-f440-4a77-9e9c-0615af3571eb" ] ;
    fhir:description [
    fhir:text [ fhir:v "pH 3.4-4.3" ]     ] ;
        ( 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 3.4 ] ;
    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 4.3 ] ;
    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 "9c0d2619-4505-4e6b-a801-bc30f84bc3e2" ] ;
    fhir:description [
    fhir:text [ fhir:v "residue <= 0.21%" ]     ] ;
        ( 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 0.21 ] ;
    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 "fc230a97-fd1a-4017-8603-822c5430a217" ] ;
    fhir:description [
    fhir:text [ fhir:v "Formaldehyde NMT 1.5%" ]     ] ;
        ( 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 1.5 ] ;
    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 "8d6688e0-7412-4d64-afe8-b73d8aec596e" ] ;
    fhir:description [
    fhir:text [ fhir:v "Impurity C NMT 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:detail [
    a fhir:Quantity ;
    fhir:value [ fhir:v "2"^^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 "f8e8343d-a37d-4b91-916b-f58d6947dc9c" ] ;
    fhir:description [
    fhir:text [ fhir:v "Unspecified Impurity NMT 0.10 % w/w" ]     ] ;
        ( 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 0.1 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent WeightToWeight" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%{WeightToWeight}" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "be7abaa1-0769-4560-af76-326e07d1df9a" ] ;
    fhir:description [
    fhir:text [ fhir:v "Total Impurities" ]     ] ;
        ( 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 0.7 ] ;
    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 "cfdd469d-020b-4047-946f-f513d58f007f" ] ;
    fhir:description [
    fhir:text [ fhir:v "Total Unidentified Impurities NMT 0.3%" ]     ] ;
        ( 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 0.3 ] ;
    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 "c5eea380-416f-4d19-a21e-c021f3c7c543" ] ;
    fhir:description [
    fhir:text [ fhir:v "RRT 2.2 NMT 0.10% w/w" ]     ] ;
        ( 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 0.1 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent WeightToWeight" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%{WeightToWeight}" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "41e19fa2-f568-443e-8bc1-6b0a6dca9d0c" ] ;
    fhir:description [
    fhir:text [ fhir:v "RRT 2.4 NMT 0.10% w/w" ]     ] ;
        ( 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 0.1 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent WeightToWeight" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%{WeightToWeight}" ]       ]     ] )
      ] [
    fhir:id [ fhir:v "e493cb3d-45b6-4463-b9b6-e588c51e032c" ] ;
    fhir:description [
    fhir:text [ fhir:v "RRT 3.41 NMT 0.10% w/w" ]     ] ;
        ( 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 0.2 ] ;
    fhir:comparator [ fhir:v "<=" ] ;
    fhir:unit [ fhir:v "percent WeightToWeight" ] ;
    fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "%{WeightToWeight}" ]       ]     ] )
      ] ) ; #
      fhir:action ( [
    fhir:linkId [ fhir:v "b9359ce8-73f3-45c5-9674-98d850053aa2" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Appearance" ] ;
    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 "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 "C138990" ] ;
    fhir:display [ fhir:v "Description/Appearance" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "EX-TEST-101" ]     ] ) ;
        ( fhir:goalId [ fhir:v "e900181a-876c-4ed6-ac96-d5a73c3d6767" ] )
      ] [
    fhir:linkId [ fhir:v "443ed163-7a7b-4d48-9462-be5532158411" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Identification" ] ;
    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 "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 "C138993" ] ;
    fhir:display [ fhir:v "Identification" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "EX-TEST-102" ]     ] ) ;
        ( fhir:goalId [ fhir:v "21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c" ] )
      ] [
    fhir:linkId [ fhir:v "058193ee-dd86-4c63-9f47-7b0608abbca4" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "pH" ] ;
    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 "C205029" ] ;
    fhir:display [ fhir:v "pH" ]       ] )     ] ) ;
        ( fhir:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "EX-TEST-103" ]     ] ) ;
        ( fhir:goalId [ fhir:v "1f476689-f440-4a77-9e9c-0615af3571eb" ] )
      ] [
    fhir:linkId [ fhir:v "940c8db4-9ed1-416e-84ec-9f9e143be8ab" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "Residue on Ignition" ] ;
    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 "9c0d2619-4505-4e6b-a801-bc30f84bc3e2" ] )
      ] [
    fhir:linkId [ fhir:v "9fca0a37-6d10-4273-a966-c026ab6eb07d" ] ;
    fhir:prefix [ fhir:v "Single Stage" ] ;
    fhir:title [ fhir:v "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 "C96103" ] ;
    fhir:display [ fhir:v "Proprietary" ]       ] ) ;
    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:documentation [
    fhir:type [ fhir:v "documentation" ] ;
    fhir:label [ fhir:v "EX-TEST-104" ]     ] ) ;
        ( fhir:goalId [ fhir:v "fc230a97-fd1a-4017-8603-822c5430a217" ] [ fhir:v "8d6688e0-7412-4d64-afe8-b73d8aec596e" ] [ fhir:v "f8e8343d-a37d-4b91-916b-f58d6947dc9c" ] [ fhir:v "be7abaa1-0769-4560-af76-326e07d1df9a" ] [ fhir:v "cfdd469d-020b-4047-946f-f513d58f007f" ] ) ;
        ( fhir:action [
    fhir:title [ fhir:v "Unidentified Impurities" ] ;
          ( fhir:action [
    fhir:prefix [ fhir:v "RRT" ] ;
    fhir:title [ fhir:v "2.2" ] ;
            ( fhir:goalId [ fhir:v "c5eea380-416f-4d19-a21e-c021f3c7c543" ] )       ] [
    fhir:prefix [ fhir:v "RRT" ] ;
    fhir:title [ fhir:v "2.4" ] ;
            ( fhir:goalId [ fhir:v "41e19fa2-f568-443e-8bc1-6b0a6dca9d0c" ] )       ] [
    fhir:prefix [ fhir:v "RRT" ] ;
    fhir:title [ fhir:v "3.41" ] ;
            ( fhir:goalId [ fhir:v "e493cb3d-45b6-4463-b9b6-e588c51e032c" ] )       ] )     ] )
      ] ) . #

    <urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf> a fhir:SubstanceDefinition ;
      fhir:id [ fhir:v "278736ef-2ddf-49e4-895c-3a9f34db36cf"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 278736ef-2ddf-49e4-895c-3a9f34db36cf</b></p><a name=\"278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><a name=\"hc278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </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-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Cochineal</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 C134009}\">Company Standard</span></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 TZ8Z31B35M}\">TZ8Z31B35M</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>Cochineal</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><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td><td><span title=\"Codes:\">Dactylopius</span></td><td><span title=\"Codes:\">cochineal</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 TUR}\">Turkey</span></td></tr></table></div>"^^rdf:XMLLiteral
      ] ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "Cochineal" ]
      ] ) ; #
      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 "C134009" ] ;
    fhir:display [ fhir:v "Company Standard" ]     ] )
      ] ) ; #
      fhir:code ( [
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "TZ8Z31B35M" ]       ] )     ]
      ] ) ; #
      fhir:name ( [
    fhir:name [ fhir:v "Cochineal" ] ;
    fhir:type [
          ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C203355" ] ;
    fhir:display [ fhir:v "GSRS Preferred Term" ]       ] )     ] ;
    fhir:preferred [ fhir:v true ]
      ] ) ; #
      fhir:sourceMaterial [
    fhir:type [
          ( 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:genus [
    fhir:text [ fhir:v "Dactylopius" ]     ] ;
    fhir:species [
    fhir:text [ fhir:v "cochineal" ]     ] ;
        ( fhir:countryOfOrigin [
          ( fhir:coding [
    fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "TUR" ] ;
    fhir:display [ fhir:v "Turkey" ]       ] )     ] )
      ] . #

    <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" ]     ]
      ] ) . #