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@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 ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "4a7e17c1-a611-4cc7-9a71-8005a8b427ab"] ; # 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><a name=\"d332acdf-4874-407b-9950-528f14c6bea2-en-US\"> </a><p><b>identifier</b>: ExampleSpecification</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use ich_3.2.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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><p><b>title</b>: Quality Specification for an example Drug Product</p></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "ExampleSpecification" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"^^xsd:anyURI ] ; fhir:code [ fhir:v "ich_3.2.p.5.1" ] ; fhir:display [ fhir:v "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/6.1.0/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>" ] ; # 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 [ 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"^^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 "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 [ 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"^^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 "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 [ 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"^^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 "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"^^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 "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"^^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 "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 [ 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"^^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 "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"^^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 "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"^^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 "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"^^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 "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"^^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:url [ fhir:v "high"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "100.5"^^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: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 [ fhir:v "6"^^xsd:integer ] ] ) ] [ 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 [ fhir:v "6"^^xsd:integer ] ] ) ] [ 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 [ fhir:v "12"^^xsd:integer ] ] ) ] ) ; # 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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><a name=\"89676a69-1fe7-422c-ab00-92abe4ef6ea9-en-US\"> </a><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>" ] ; # 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><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a-en-US\"> </a><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>" ] ; # 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" ] ] ] ) . #
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-12
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