Pharmaceutical Quality (Industry)
1.0.0 - STU1

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

## : Example: Bundle – Analytical Procedure, product - TTL Representation

Raw ttl | Download

    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
    @prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

    # - resource -------------------------------------------------------------------

    #  Product Analytical Procedure

     a fhir:Bundle ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "bundle-analytical-procedure-pq-ex1-prod"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq>     ] )
      ] ; #
      fhir:type [ fhir:v "collection"] ; #
      fhir:entry ( [
    fhir:fullUrl [ fhir:v "urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f81"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f81> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4036-3c2f-b8ba6a7d046e"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:12e7e672-40a6-4036-3c2f-b8ba6a7d046e> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4036-3c3f-b8ba6a7d046e"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:12e7e672-40a6-4036-3c3f-b8ba6a7d046e> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5> )
      ] ) . #

    <urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f> a fhir:PlanDefinition ;
      fhir:id [ fhir:v "analyticalProcedure"] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_analyticalProcedure\"> </a><p><b>Generated Narrative: PlanDefinition</b><a name=\"analyticalProcedure\"> </a><a name=\"hcanalyticalProcedure\"> </a></p><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\">Resource PlanDefinition &quot;analyticalProcedure&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: Analytical Procedure</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-pharmaceutical-plan-type.html\">Pharmaceutical Plan Type Codes</a>#analytical-procedure &quot;Analytical Procedure&quot;)</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5</p><blockquote><p><b>action</b></p><p><b>title</b>: Preparation and Analysis of Drug Product Samples</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Diluent</span></p><p><b>role</b>: Diluent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-participant-role.html\">Manufacturing Participant Role Codes</a>#diluent)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Resulting material</span></p><p><b>role</b>: Resulting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-participant-role.html\">Manufacturing Participant Role Codes</a>#ResultingMaterial)</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Preparation</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Analysis</p><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>"
      ] ; #
      fhir:url [ fhir:v "http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f"^^xsd:anyURI] ; # http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
      fhir:title [ fhir:v "Analytical Procedure"] ; #
      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://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "analytical-procedure" ] ;
    fhir:display [ fhir:v "Analytical Procedure" ]     ] )
      ] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:subject [
    a fhir:Reference ;
    fhir:reference [ fhir:v "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" ] # MedicinalProductDefinition\/medicinalproductdefinition-drug-product-dxpq-ex1
      ] ; #
      fhir:action ( [
    fhir:title [ fhir:v "Preparation and Analysis of Drug Product Samples" ] ;
        ( fhir:participant [
    fhir:typeReference [
            ( fhir:extension [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:reference [ fhir:v "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f81" ] # SubstanceDefinition\/diluent           ]         ] ) ;
    fhir:display [ fhir:v "Diluent" ]       ] ;
    fhir:role [
            ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "diluent" ] ;
    fhir:display [ fhir:v "Diluent" ]         ] )       ]     ] [
    fhir:typeReference [
            ( fhir:extension [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:reference [ fhir:v "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f82" ] # SubstanceDefinition\/resultingMaterial           ]         ] ) ;
    fhir:display [ fhir:v "Resulting material" ]       ] ;
    fhir:role [
            ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "ResultingMaterial" ] ;
    fhir:display [ fhir:v "Resulting Material" ]         ] )       ]     ] ) ;
        ( fhir:action [
    fhir:title [ fhir:v "Sample Preparation" ] ;
          ( fhir:action [
    fhir:title [ fhir:v "Instructions" ] ;
    fhir:description [ fhir:v "Transfer 5 tablets into a volumetric flask. Add a portion of the diluent and shake on mechanical shaker until tablets are completely disintegrated. Dilute to volume with diluent. Do not exceed 2 mg/mL in the initial dilution. Filter or centrifuge." ]       ] )     ] [
    fhir:title [ fhir:v "Sample Analysis" ] ;
          ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e>         ]       ] )     ] )
      ] ) . #

    <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f81> a fhir:SubstanceDefinition ;
      fhir:id [ fhir:v "9f69ec9c-5fd1-30d2-0790-9e8035565f81"] ; # diluent
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_9f69ec9c-5fd1-30d2-0790-9e8035565f81\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-5fd1-30d2-0790-9e8035565f81\"> </a><a name=\"hc9f69ec9c-5fd1-30d2-0790-9e8035565f81\"> </a></p><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\">Resource SubstanceDefinition &quot;9f69ec9c-5fd1-30d2-0790-9e8035565f81&quot; </p></div><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>0.05 % trifluoroacetic acid (TFA) in 50:50 acetonitrile: water (v/v)</td></tr></table></div>"
      ] ; #
      fhir:name ( [
    fhir:name [ fhir:v "0.05 % trifluoroacetic acid (TFA) in 50:50 acetonitrile: water (v/v)" ]
      ] ) . #

    <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82> a fhir:SubstanceDefinition ;
      fhir:id [ fhir:v "9f69ec9c-5fd1-30d2-0790-9e8035565f82"] ; # resultingMaterial
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </a><a name=\"hc9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </a></p><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\">Resource SubstanceDefinition &quot;9f69ec9c-5fd1-30d2-0790-9e8035565f82&quot; </p></div><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbat in Diluent (approximately 0.36 mg/mL)</td></tr></table></div>"
      ] ; #
      fhir:name ( [
    fhir:name [ fhir:v "Stelbat in Diluent (approximately 0.36 mg/mL)" ]
      ] ) . #

    <urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e> a fhir:ObservationDefinition ;
      fhir:id [ fhir:v "12e7e672-40a6-4136-3c1f-b8ba6a7d046e"] ; # SampleAnalysis
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </a><a name=\"hc12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </a></p><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\">Resource ObservationDefinition &quot;12e7e672-40a6-4136-3c1f-b8ba6a7d046e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Sample Analysis</p><p><b>status</b>: active</p><p><b>description</b>: Number of Injections: 1 of each preparation</p><p><b>code</b>:  <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</p><p><b>hasMember</b>: </p><ul><li>See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</li><li>See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</li></ul></div>"
      ] ; #
      fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e
      fhir:title [ fhir:v "Sample Analysis"] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:description [ fhir:v "Number of Injections: 1 of each preparation"] ; #
      fhir:code [
        ( fhir:extension [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/data-absent-reason"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "unsupported" ]     ] )
      ] ; #
      fhir:specimen ( [
    fhir:reference [ fhir:v "SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" ] # SpecimenDefinition\/specimendefinition
      ] ) ; #
      fhir:hasMember ( [
    fhir:reference [ fhir:v "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e" ] # ObservationDefinition\/Assay
      ] [
    fhir:reference [ fhir:v "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e" ] # ObservationDefinition\/Identity
      ] ) . #

    <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e> a fhir:ObservationDefinition ;
      fhir:id [ fhir:v "12e7e672-40a6-4036-3c1f-b8ba6a7d045e"] ; # Assay
      fhir:text [
    fhir:status [ fhir:v "additional" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n                  <div style=\"font-family: 'Times New Roman', Times, serif;\">\n                     <p>Determine the amount of Stelbat in each sample replicate as follows:</p>\n                     <p>\n                            \n                              <!-- <img alt=\"formula\" width=\"203\" height=\"34\" style=\"display: block; margin-left: auto; margin-right: auto;\" src=\"#imageResource\"/> -->\n                        </p>\n                     <p>\n                        <span>Where:</span>\n                     </p>\n                     <p>\n                        <span>A\n                                <sub>SPL</sub>      =  Area of Stelbat in the sample \n                            </span>\n                     </p>\n                     <p>\n                        <span>ANSR   =  Average normalized standard response factor of standard injections</span>\n                     </p>\n                     <p>\n                        <span>DF     =  Overall sample dilution factor</span>\n                     </p>\n                     <p>\n                        <span>N      = Number of tablets in sample preparation</span>\n                     </p>\n                     <p>\n                        <span>Determine the % label claim of the sample as follows:</span>\n                     </p>\n                     <p>\n                            \n                              <!-- <img alt=\"formula\" width=\"220\" height=\"34\" style=\"display: block; margin-left: auto; margin-right: auto;\" src=\"#imageResource2\"/> -->\n                        </p>\n                     <p>\n                        <span>Where:</span>\n                     </p>\n                     <p>\n                        <span>LC       =          Label claim (mg/tablet) of tested sample</span>\n                     </p>\n                  </div>\n               </div>"
      ] ; #
      fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
      fhir:title [ fhir:v "Assay (w/w%)"] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:code [
        ( fhir:coding [
    fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "ASSAY" ] ;
    fhir:display [ fhir:v "Assay" ]     ] ) ;
    fhir:text [ fhir:v "Assay (w/w%)" ]
      ] ; #
      fhir:qualifiedValue ( [
        ( fhir:extension [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "The %RSD between the two assay results must be ≤ 1.5%" ]     ] )
      ] ) . #

    <urn:uuid:12e7e672-40a6-4036-3c2f-b8ba6a7d046e> a fhir:Binary ;
      fhir:id [ fhir:v "imageResource"] ; #
      fhir:contentType [ fhir:v "image/png"] ; #  example format
      fhir:data [ fhir:v " "^^xsd:base64Binary] . #  data is base 64 encoded, actual bytes of the image png file

    <urn:uuid:12e7e672-40a6-4036-3c3f-b8ba6a7d046e> a fhir:Binary ;
      fhir:id [ fhir:v "imageResource2"] ; #
      fhir:contentType [ fhir:v "image/png"] ; #  example format
      fhir:data [ fhir:v " "^^xsd:base64Binary] . #  data is base 64 encoded, actual bytes of the image png file

    <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e> a fhir:ObservationDefinition ;
      fhir:id [ fhir:v "12e7e672-40a6-4036-3c1f-b8ba6a7d046e"] ; # Identity
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </a><a name=\"hc12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </a></p><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\">Resource ObservationDefinition &quot;12e7e672-40a6-4036-3c1f-b8ba6a7d046e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Identity</p><p><b>status</b>: active</p><p><b>code</b>: Identity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#IDT &quot;Identification&quot;)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td>, </td></tr></table></div>"
      ] ; #
      fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e
      fhir:title [ fhir:v "Identity"] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:code [
        ( fhir:coding [
    fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "IDT" ] ;
    fhir:display [ fhir:v "Identification" ]     ] ) ;
    fhir:text [ fhir:v "Identity" ]
      ] ; #
      fhir:qualifiedValue ( [
        ( fhir:extension [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "1. The retention time ratio of the sample peak to standard peak is within 0.95 to 1.05." ]     ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "2. The UV spectrum of the sample peak compares favorably to the UV spectrum of the standard peak from 210 nm to 400 nm." ]     ] )
      ] ) . #

    <urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2> a fhir:SpecimenDefinition ;
      fhir:id [ fhir:v "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"] ; # specimendefinition
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </a><p><b>Generated Narrative: SpecimenDefinition</b><a name=\"3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </a><a name=\"hc3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </a></p><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\">Resource SpecimenDefinition &quot;3a0cde98-4a73-6d67-1dfc-08e3fc9646a2&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</code></p><p><b>status</b>: active</p><p><b>description</b>: Number of Preparations: 2 (only 1 is required for identity)</p><blockquote><p><b>typeTested</b></p><p><b>preference</b>: preferred</p><blockquote><p><b>handling</b></p><h3>MaxDurations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Value</b></td><td><b>Unit</b></td></tr><tr><td style=\"display: none\">*</td><td>4</td><td>days</td></tr></table><p><b>instruction</b>: at ambient or refrigerated conditions protected from light (may be extended with supporting data)</p></blockquote></blockquote></div>"
      ] ; #
      fhir:url [ fhir:v "http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"^^xsd:anyURI] ; # http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
      fhir:status [ fhir:v "active"] ; #
      fhir:description [ fhir:v "Number of Preparations: 2 (only 1 is required for identity)"] ; #
      fhir:typeTested ( [
    fhir:preference [ fhir:v "preferred" ] ;
        ( fhir:handling [
    fhir:maxDuration [
    fhir:value [ fhir:v "4"^^xsd:decimal ] ;
    fhir:unit [ fhir:v "days" ]       ] ;
    fhir:instruction [ fhir:v "at ambient or refrigerated conditions protected from light (may be extended with supporting data)" ]     ] )
      ] ) . #

    <urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5> a fhir:MedicinalProductDefinition ;
      fhir:id [ fhir:v "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"] ; # medicinalproductdefinition-drug-product-dxpq-ex1
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a><a name=\"hca0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a></p><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\">Resource MedicinalProductDefinition &quot;a0694a7a-aafa-4cbe-8135-c788a9a4d3d5&quot; </p></div><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-productNameType-pq-example.html\">Product Name Type - example</a>#Proprietary)</span></p><h3>Parts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>20mg</td><td>Strength part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html\">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>"
      ] ; #
      fhir:combinedPharmaceuticalDoseForm [
        ( fhir:coding [
    fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "10225000" ] ;
    fhir:display [ fhir:v "Gastro-resistant tablet" ]     ] )
      ] ; #
      fhir:route ( [
        ( fhir:coding [
    fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "20053000" ] ;
    fhir:display [ fhir:v "Oral use" ]     ] )
      ] ) ; #
      fhir:name ( [
    fhir:productName [ fhir:v "Stelbat Tablets, 20mg" ] ;
    fhir:type [
          ( fhir:coding [
    fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "Proprietary" ] ;
    fhir:display [ fhir:v "Proprietary" ]       ] )     ] ;
        ( fhir:part [
    fhir:part [ fhir:v "20mg" ] ;
    fhir:type [
            ( fhir:coding [
    fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-name-part-type"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "StrengthPart" ] ;
    fhir:display [ fhir:v "Strength part" ]         ] )       ]     ] )
      ] ) . #