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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 "7ce2088d-d281-4e2f-9a25-120a1f9805d1"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23> ] ) ] ; # fhir:identifier [ fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ; fhir:value [ fhir:v "urn:uuid:7ce2088d-d281-4e2f-9a25-120a1f9805d1" ] ] ; # fhir:type [ fhir:v "document"] ; # fhir:timestamp [ fhir:v "2023-12-05T01:34:39.503Z"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "urn:uuid:5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:5c0d341e-6e4f-457c-811d-cfaf3eb62ecd> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:d3a11b25-e160-4688-b807-6383364096fd"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:d3a11b25-e160-4688-b807-6383364096fd> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519> ) ] ) . # <urn:uuid:5c0d341e-6e4f-457c-811d-cfaf3eb62ecd> a fhir:Composition ; fhir:id [ fhir:v "5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 5c0d341e-6e4f-457c-811d-cfaf3eb62ecd</b></p><a name=\"5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </a><a name=\"hc5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </a><a name=\"5c0d341e-6e4f-457c-811d-cfaf3eb62ecd-en-US\"> </a><p><b>identifier</b>: materials1</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.s.2.3}\">Control of Materials</span></p><p><b>date</b>: 2023-12-05 01:34:39+0000</p><p><b>author</b>: <a href=\"Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-49438799-e286-432c-b8d8-68ac77e7f519\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>title</b>: Control of Materials Example</p></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "materials1" ] ] ) ; # 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.s.2.3" ] ; fhir:display [ fhir:v "Control of Materials" ] ] ) ] ; # fhir:subject ( [ fhir:reference [ fhir:v "urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a" ] ] ) ; # fhir:date [ fhir:v "2023-12-05T01:34:39.502Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519" ] ] ) ; # fhir:title [ fhir:v "Control of Materials Example"] ; # fhir:section ( [ fhir:code [ ( 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.s.3.1" ] ; fhir:display [ fhir:v "Elucidation of Structure and other Characteristics" ] ] ) ] ; ( fhir:entry [ fhir:reference [ fhir:v "urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e" ] ] ) ] [ fhir:code [ ( 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.s.3.1" ] ; fhir:display [ fhir:v "Elucidation of Structure and other Characteristics" ] ] ) ] ; ( fhir:entry [ fhir:reference [ fhir:v "urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b" ] ] ) ] [ fhir:code [ ( 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.s.3.1" ] ; fhir:display [ fhir:v "Elucidation of Structure and other Characteristics" ] ] ) ] ; ( fhir:entry [ fhir:reference [ fhir:v "urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89" ] ] ) ] ) . # <urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "cd84a8b5-4e96-551c-15c6-c97c943eb38a"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a</b></p><a name=\"cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><a name=\"hccd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><a name=\"cd84a8b5-4e96-551c-15c6-c97c943eb38a-en-US\"> </a><p><b>identifier</b>: salicylate</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><p><b>manufacturer</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov R16CO5Y76E}\">R16CO5Y76E</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: ACETYLSALICYLIC ACID</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C97054}\">Generic Name</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: ASPIRIN</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></p><p><b>preferred</b>: true</p></blockquote></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "salicylate" ] ] ) ; # fhir:classification ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48807" ] ; fhir:display [ fhir:v "Chemical" ] ] ) ] ) ; # fhir:grade ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134006" ] ; fhir:display [ fhir:v "USP-NF" ] ] ) ] ) ; # fhir:manufacturer ( [ fhir:reference [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5" ] ] ) ; # fhir:code ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ; fhir:code [ fhir:v "R16CO5Y76E" ] ] ) ] ] ) ; # fhir:name ( [ fhir:name [ fhir:v "ACETYLSALICYLIC ACID" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C97054" ] ; fhir:display [ fhir:v "Generic Name" ] ] ) ] ] [ fhir:name [ fhir:v "ASPIRIN" ] ; 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"^^xsd:boolean ] ] ) . # <urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579> a fhir:Organization ; fhir:id [ fhir:v "4b565cf3-5353-48af-8cd6-5ccf4e9fd579"] ; # 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_4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579</b></p><a name=\"4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><a name=\"hc4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><a name=\"4b565cf3-5353-48af-8cd6-5ccf4e9fd579-en-US\"> </a><p><b>identifier</b>: DUNS/783452221, FEI/6913973</p><p><b>name</b>: Manufacturing Site (J. Jones Research)</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>Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States</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 "783452221" ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134004" ] ; fhir:display [ fhir:v "FEI" ] ] ) ] ; fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ; fhir:value [ fhir:v "6913973" ] ] ) ; # fhir:name [ fhir:v "Manufacturing Site (J. Jones Research)"] ; # fhir:contact ( [ fhir:address [ fhir:type [ fhir:v "postal" ] ; fhir:text [ fhir:v "Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States" ] ; ( fhir:line [ fhir:v "444 Grant Street" ] ) ; fhir:city [ fhir:v "Bedford" ] ; fhir:state [ fhir:v "NY" ] ; fhir:postalCode [ fhir:v "15600" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . # <urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5> a fhir:Organization ; fhir:id [ fhir:v "e99bddfa-c1b5-435b-bbe8-24816b4e23e5"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5</b></p><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"hce99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5-en-US\"> </a><p><b>identifier</b>: DUNS/143265222, FEI/6981397</p><p><b>name</b>: Vidinaid</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134003" ] ; fhir:display [ fhir:v "DUNS" ] ] ) ] ; fhir:system [ fhir:v "urn:oid:1.3.6.1.4.1.519.1"^^xsd:anyURI ] ; fhir:value [ fhir:v "143265222" ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134004" ] ; fhir:display [ fhir:v "FEI" ] ] ) ] ; fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ; fhir:value [ fhir:v "6981397" ] ] ) ; # fhir:name [ fhir:v "Vidinaid"] ; # fhir:contact ( [ fhir:address [ fhir:type [ fhir:v "postal" ] ; fhir:text [ fhir:v "Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA" ] ; ( fhir:line [ fhir:v "100 Stillwater Avenue" ] [ fhir:v "Building #2" ] ) ; fhir:city [ fhir:v "Bangor" ] ; fhir:state [ fhir:v "ME" ] ; fhir:postalCode [ fhir:v "04401" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . # <urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049> a fhir:Organization ; fhir:id [ fhir:v "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</b></p><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049-en-US\"> </a><p><b>identifier</b>: DUNS/173265332</p><p><b>name</b>: Mega Chem Supply</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Mega Chem Supply, 350 W Main Street, Rochester, NY, United States</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134003" ] ; fhir:display [ fhir:v "DUNS" ] ] ) ] ; fhir:system [ fhir:v "urn:oid:1.3.6.1.4.1.519.1"^^xsd:anyURI ] ; fhir:value [ fhir:v "173265332" ] ] ) ; # fhir:name [ fhir:v "Mega Chem Supply"] ; # fhir:contact ( [ fhir:address [ fhir:type [ fhir:v "postal" ] ; fhir:text [ fhir:v "Mega Chem Supply, 350 W Main Street, Rochester, NY, United States" ] ; ( fhir:line [ fhir:v "350 W Main Street" ] ) ; fhir:city [ fhir:v "Rochester" ] ; fhir:state [ fhir:v "NY" ] ; fhir:postalCode [ fhir:v "14608" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . # <urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "0efb1188-04f0-44ba-bfe7-ca6169ca8703"] ; # 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_0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 0efb1188-04f0-44ba-bfe7-ca6169ca8703</b></p><a name=\"0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><a name=\"hc0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><a name=\"0efb1188-04f0-44ba-bfe7-ca6169ca8703-en-US\"> </a><p><b>identifier</b>: carrageenan</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C103206}\">Structurally Diverse Substance</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}\">Company Standard</span></p><p><b>manufacturer</b>: <a href=\"Bundle-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-4b565cf3-5353-48af-8cd6-5ccf4e9fd579\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 5C69YCD2YJ}\">5C69YCD2YJ</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>Carrageenan</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 C14258}\">Plant</span></td><td><span title=\"Codes:\">palmaria</span></td><td><span title=\"Codes:\">palmata</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 USA}\">United States of America</span></td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "carrageenan" ] ] ) ; # fhir:classification ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C103206" ] ; fhir:display [ fhir:v "Structurally Diverse Substance" ] ] ) ] ) ; # 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:manufacturer ( [ fhir:reference [ fhir:v "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579" ] ] ) ; # fhir:code ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ; fhir:code [ fhir:v "5C69YCD2YJ" ] ] ) ] ] ) ; # fhir:name ( [ fhir:name [ fhir:v "Carrageenan" ] ; 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"^^xsd:boolean ] ] ) ; # 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 "C14258" ] ; fhir:display [ fhir:v "Plant" ] ] ) ] ; fhir:genus [ fhir:text [ fhir:v "palmaria" ] ] ; fhir:species [ fhir:text [ fhir:v "palmata" ] ] ; ( fhir:countryOfOrigin [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "USA" ] ; fhir:display [ fhir:v "United States of America" ] ] ) ] ) ] . # <urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "fd84a8b5-9e96-451c-a5c6-097c943eb38a"] ; # 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_fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition fd84a8b5-9e96-451c-a5c6-097c943eb38a</b></p><a name=\"fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><a name=\"hcfd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><a name=\"fd84a8b5-9e96-451c-a5c6-097c943eb38a-en-US\"> </a><p><b>identifier</b>: Citric acid</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}\">Company Standard</span></p><p><b>manufacturer</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov XF417D3PSL}\">XF417D3PSL</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>ANHYDROUS CITRIC ACID</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></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></tr></table></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "Citric acid" ] ] ) ; # fhir:classification ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48807" ] ; fhir:display [ fhir:v "Chemical" ] ] ) ] ) ; # fhir:grade ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134009" ] ; fhir:display [ fhir:v "Company Standard" ] ] ) ] ) ; # fhir:manufacturer ( [ fhir:reference [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5" ] ] ) ; # fhir:supplier ( [ fhir:reference [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" ] ] ) ; # fhir:code ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ; fhir:code [ fhir:v "XF417D3PSL" ] ] ) ] ] ) ; # fhir:name ( [ fhir:name [ fhir:v "ANHYDROUS CITRIC ACID" ] ; 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"^^xsd:boolean ] ] ) ; # 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" ] ] ) ] ] . # <urn:uuid:d3a11b25-e160-4688-b807-6383364096fd> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "d3a11b25-e160-4688-b807-6383364096fd"] ; # 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_d3a11b25-e160-4688-b807-6383364096fd\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition d3a11b25-e160-4688-b807-6383364096fd</b></p><a name=\"d3a11b25-e160-4688-b807-6383364096fd\"> </a><a name=\"hcd3a11b25-e160-4688-b807-6383364096fd\"> </a><a name=\"d3a11b25-e160-4688-b807-6383364096fd-en-US\"> </a><p><b>identifier</b>: water</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 C176793}\">BP</span></p><p><b>manufacturer</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 059QF0KO0R}\">059QF0KO0R</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>WATER</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></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></tr></table></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "water" ] ] ) ; # 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 "C176793" ] ; fhir:display [ fhir:v "BP" ] ] ) ] ) ; # fhir:manufacturer ( [ fhir:reference [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5" ] ] ) ; # fhir:supplier ( [ fhir:reference [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" ] ] ) ; # fhir:code ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ; fhir:code [ fhir:v "059QF0KO0R" ] ] ) ] ] ) ; # fhir:name ( [ fhir:name [ fhir:v "WATER" ] ; 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"^^xsd:boolean ] ] ) ; # 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" ] ] ) ] ] . # <urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e> a fhir:PlanDefinition ; fhir:id [ fhir:v "ab241f8c-d21e-4382-a70a-52190dbdf07e"] ; # 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_ab241f8c-d21e-4382-a70a-52190dbdf07e\"> </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;\">ab241f8c-d21e-4382-a70a-52190dbdf07e</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>RawCitricacid</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;\">Raw Material (Carrageenan) 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/6.1.0/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>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:0efb1188-04f0-44ba-bfe7-ca6169ca8703</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;\">2023-11-28</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 Identification:</b> \n \n <br/>\n \n \n \n <b>Then:</b>\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b> Identification A:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Identification B:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Identification C:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Identification D:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n </table>\n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Microbial Limits:</b> \n \n <br/>\n \n \n \n <b>Then:</b>\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b> Total Bacterial Count:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Salmonella:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Escherichia Coli:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n </table>\n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Elemental 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> Cadmium (Cd):</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Mercury (Hg):</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Arsenic (As):</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Lead (Pb):</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n </table>\n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Residual Solvents:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Impurity: Insoluble Matter:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Solubility in H2O:</b> \n \n <br/>\n \n \n \n \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 "C48660" ] ; fhir:display [ fhir:v "Not Applicable" ] ] ) ] ] ) ; # fhir:identifier ( [ fhir:value [ fhir:v "RawCitricacid" ] ] ) ; # fhir:version [ fhir:v "1.0"] ; # fhir:title [ fhir:v "Raw Material (Carrageenan) 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:0efb1188-04f0-44ba-bfe7-ca6169ca8703" ] ] ; # fhir:date [ fhir:v "2023-11-28"^^xsd:date] ; # fhir:goal ( [ fhir:id [ fhir:v "e512320e-0ffb-47d9-922a-5415aaa4cb30" ] ; fhir:description [ fhir:text [ fhir:v "Viscous upon cooling" ] ] ; ( 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 "Viscous upon cooling" ] ] ) ] [ fhir:id [ fhir:v "2c6e465b-4dec-4a09-9dc5-58c480009d27" ] ; fhir:description [ fhir:text [ fhir:v "Kappa, iota or lambda" ] ] ; ( 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 "Kappa, iota or Lambda" ] ] ) ] [ fhir:id [ fhir:v "c233a5f7-37e2-4b2b-9f04-cf1b25534865" ] ; fhir:description [ fhir:text [ fhir:v "Blue, stringy precipitate forms" ] ] ; ( 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 "Blue stringy precipitate forms" ] ] ) ] [ fhir:id [ fhir:v "c759888d-1eac-4a12-aa9b-403f395f2c18" ] ; fhir:description [ fhir:text [ fhir:v "FTIR matches 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 "FTIR matches standard" ] ] ) ] [ fhir:id [ fhir:v "66d4035c-633a-49b1-b974-e3171911f44a" ] ; fhir:description [ fhir:text [ fhir:v "max 200 cfu/g" ] ] ; ( 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 "200"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "colony forming unit" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "[CFU]" ] ] ] ) ] [ fhir:id [ fhir:v "95bf9d43-f337-4905-9c50-788b69d00843" ] ; fhir:description [ fhir:text [ fhir:v "Negative" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ fhir:v "Negative" ] ] ) ] [ fhir:id [ fhir:v "4e475e2c-c235-4433-b1e4-201a17e45796" ] ; fhir:description [ fhir:text [ fhir:v "Negative" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ fhir:v "Negative" ] ] ) ] [ fhir:id [ fhir:v "af4ec6c3-4590-43f7-92e0-c8dae0e76e1f" ] ; fhir:description [ fhir:text [ fhir:v "As Reported" ] ] ; ( 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 "As Reported" ] ] ) ] [ fhir:id [ fhir:v "b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73" ] ; fhir:description [ fhir:text [ fhir:v "As Reported" ] ] ; ( 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 "As Reported" ] ] ) ] [ fhir:id [ fhir:v "464f3063-0a4b-4408-9f4a-d6c0b8170097" ] ; fhir:description [ fhir:text [ fhir:v "<= 3 ppm" ] ] ; ( 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 "3"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "part per million" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "[ppm]" ] ] ] ) ] [ fhir:id [ fhir:v "03fbc16c-d4d4-40ac-8689-448bda831dac" ] ; fhir:description [ fhir:text [ fhir:v "<= 10 ppm" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "10"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "part per million" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "[ppm]" ] ] ] ) ] [ fhir:id [ fhir:v "28aba010-126e-4c47-8611-367cdacdd87e" ] ; fhir:description [ fhir:text [ fhir:v "As Reported" ] ] ; ( 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 "As Reported" ] ] ) ] [ fhir:id [ fhir:v "4b3aa353-3bc7-463f-b4c2-defd041da2c7" ] ; fhir:description [ fhir:text [ fhir:v "<= 2.0%" ] ] ; ( 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 "8125f603-96e7-4f3e-8b13-c15c5870e6e6" ] ; fhir:description [ fhir:text [ fhir:v "<30ml H2O @ 25C" ] ] ; ( 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 "30"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "milliliter" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mL" ] ] ] [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "25"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "degree Celsius" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "Cel" ] ] ] ) ] ) ; # fhir:action ( [ fhir:id [ fhir:v "428fa917-a7d3-4515-9b48-c9366acd673a" ] ; 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 "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 "C138993" ] ; fhir:display [ fhir:v "Identification" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-001" ] ] ) ; ( fhir:action [ fhir:title [ fhir:v "Identification A" ] ; ( fhir:goalId [ fhir:v "e512320e-0ffb-47d9-922a-5415aaa4cb30" ] ) ] [ fhir:title [ fhir:v "Identification B" ] ; ( fhir:goalId [ fhir:v "2c6e465b-4dec-4a09-9dc5-58c480009d27" ] ) ] [ fhir:title [ fhir:v "Identification C" ] ; ( fhir:goalId [ fhir:v "c233a5f7-37e2-4b2b-9f04-cf1b25534865" ] ) ] [ fhir:title [ fhir:v "Identification D" ] ; ( fhir:goalId [ fhir:v "c759888d-1eac-4a12-aa9b-403f395f2c18" ] ) ] ) ] [ fhir:id [ fhir:v "f7cbb73f-4220-4987-b498-c049230091ea" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Microbial 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 "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 "C134256" ] ; fhir:display [ fhir:v "Microbial Limits" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-002" ] ] ) ; ( fhir:action [ fhir:title [ fhir:v "Total Bacterial Count" ] ; ( fhir:goalId [ fhir:v "66d4035c-633a-49b1-b974-e3171911f44a" ] ) ] [ fhir:title [ fhir:v "Salmonella" ] ; ( fhir:goalId [ fhir:v "95bf9d43-f337-4905-9c50-788b69d00843" ] ) ] [ fhir:title [ fhir:v "Escherichia Coli" ] ; ( fhir:goalId [ fhir:v "4e475e2c-c235-4433-b1e4-201a17e45796" ] ) ] ) ] [ fhir:id [ fhir:v "f5f8221c-f9ec-4b47-8ec7-90ff44f7388c" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Elemental 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 "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 "EX-TEST-003" ] ] ) ; ( fhir:action [ fhir:title [ fhir:v "Cadmium (Cd)" ] ; ( fhir:goalId [ fhir:v "af4ec6c3-4590-43f7-92e0-c8dae0e76e1f" ] ) ] [ fhir:title [ fhir:v "Mercury (Hg)" ] ; ( fhir:goalId [ fhir:v "b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73" ] ) ] [ fhir:title [ fhir:v "Arsenic (As)" ] ; ( fhir:goalId [ fhir:v "464f3063-0a4b-4408-9f4a-d6c0b8170097" ] ) ] [ fhir:title [ fhir:v "Lead (Pb)" ] ; ( fhir:goalId [ fhir:v "03fbc16c-d4d4-40ac-8689-448bda831dac" ] ) ] ) ] [ fhir:id [ fhir:v "37b44e91-529a-4d87-843b-ec3dd172c09f" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Residual Solvents" ] ; 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 "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 "EX-TEST-004" ] ] ) ; ( fhir:goalId [ fhir:v "28aba010-126e-4c47-8611-367cdacdd87e" ] ) ] [ fhir:id [ fhir:v "25a64081-a0c2-4d72-8a48-538f81fcc35f" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Impurity: Insoluble Matter" ] ; 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 "C204971" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-005" ] ] ) ; ( fhir:goalId [ fhir:v "4b3aa353-3bc7-463f-b4c2-defd041da2c7" ] ) ] [ fhir:id [ fhir:v "055a79d2-3f6b-49ec-a129-6feac5c33812" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Solubility in H2O" ] ; 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 "C60821" ] ; fhir:display [ fhir:v "Solubility" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-006" ] ] ) ; ( fhir:goalId [ fhir:v "8125f603-96e7-4f3e-8b13-c15c5870e6e6" ] ) ] ) . # <urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b> a fhir:PlanDefinition ; fhir:id [ fhir:v "a2cba634-a481-4b07-9bd4-62c7ada31e1b"] ; # 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_a2cba634-a481-4b07-9bd4-62c7ada31e1b\"> </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;\">a2cba634-a481-4b07-9bd4-62c7ada31e1b</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>CitricAcidSpecification</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;\">Citric acid 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/6.1.0/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>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:fd84a8b5-9e96-451c-a5c6-097c943eb38a</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 </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 "C48660" ] ; fhir:display [ fhir:v "Not Applicable" ] ] ) ] ] ) ; # fhir:identifier ( [ fhir:value [ fhir:v "CitricAcidSpecification" ] ] ) ; # fhir:version [ fhir:v "1.0"] ; # fhir:title [ fhir:v "Citric acid 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:fd84a8b5-9e96-451c-a5c6-097c943eb38a" ] ] ; # fhir:date [ fhir:v "2023-12-01"^^xsd:date] ; # fhir:goal ( [ fhir:id [ fhir:v "9bc2bfdf-c9b1-440a-bafe-89f2674341d4" ] ; 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 [ fhir:v "White solid" ] ] ) ] [ fhir:id [ fhir:v "59e2c94a-d383-4776-9b00-3b97b0741c9a" ] ; 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 [ fhir:v "IR spectrum conforms to reference standard" ] ] ) ] [ fhir:id [ fhir:v "a2ed2d13-e96a-4d7b-b825-c69afd334cf7" ] ; 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"^^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 "4.3"^^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 "e046aab8-b10f-4e13-89e6-bfa869a90b38" ] ; 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"^^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:action ( [ fhir:id [ fhir:v "fdf5e37f-ae97-48c1-9809-33aebff37199" ] ; 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 [ 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 "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 "9bc2bfdf-c9b1-440a-bafe-89f2674341d4" ] ) ] [ fhir:id [ fhir:v "f6da4e9e-4954-4fd1-a78a-b297fea64a6f" ] ; 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 [ 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 "59e2c94a-d383-4776-9b00-3b97b0741c9a" ] ) ] [ fhir:id [ fhir:v "a5beeff6-dcc1-4b42-8ea1-76dea4b0da1d" ] ; 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 [ 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 "a2ed2d13-e96a-4d7b-b825-c69afd334cf7" ] ) ] [ fhir:id [ fhir:v "aad4c3ce-985d-45ab-9d00-c2c01ca3813f" ] ; 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 [ 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 "e046aab8-b10f-4e13-89e6-bfa869a90b38" ] ) ] ) . # <urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89> a fhir:PlanDefinition ; fhir:id [ fhir:v "5819b223-d3d2-419f-b617-b3a9a3625b89"] ; # 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_5819b223-d3d2-419f-b617-b3a9a3625b89\"> </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;\">5819b223-d3d2-419f-b617-b3a9a3625b89</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>WaterSpecification</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;\">Water 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/6.1.0/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>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:d3a11b25-e160-4688-b807-6383364096fd</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 Color degree:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Turbidity:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Smell and taste:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Total hardness:</b> \n \n <br/>\n \n \n \n \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 "C48660" ] ; fhir:display [ fhir:v "Not Applicable" ] ] ) ] ] ) ; # fhir:identifier ( [ fhir:value [ fhir:v "WaterSpecification" ] ] ) ; # fhir:version [ fhir:v "1.0"] ; # fhir:title [ fhir:v "Water 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:d3a11b25-e160-4688-b807-6383364096fd" ] ] ; # fhir:date [ fhir:v "2023-12-01"^^xsd:date] ; # fhir:goal ( [ fhir:id [ fhir:v "1779ee35-8725-4322-ae82-89ed499f6864" ] ; fhir:description [ fhir:text [ fhir:v "<=12 deg" ] ] ; ( 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 "12"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "degree" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "deg" ] ] ] ) ] [ fhir:id [ fhir:v "2897e150-8465-48c7-9269-1cda86dc3075" ] ; fhir:description [ fhir:text [ fhir:v "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:target [ fhir:detail [ fhir:v "Conforms to reference standard" ] ] ) ] [ fhir:id [ fhir:v "9c86ccba-a210-4ce5-9a23-b145d9f123c6" ] ; fhir:description [ fhir:text [ fhir:v "Odorless" ] ] ; ( 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 "Odorless" ] ] ) ] [ fhir:id [ fhir:v "de0f0d85-5617-4b07-98fc-9976b2dbf216" ] ; fhir:description [ fhir:text [ fhir:v "<= 395mg/L" ] ] ; ( 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 "395"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "milligram" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mg" ] ] ] ) ] ) ; # fhir:action ( [ fhir:id [ fhir:v "3668eb6f-797c-4325-8f41-160c951b4adc" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Color degree" ] ; 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 "Colorimetry" ] ] ; ( 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 "EX-TEST-201" ] ] ) ; ( fhir:goalId [ fhir:v "1779ee35-8725-4322-ae82-89ed499f6864" ] ) ] [ fhir:id [ fhir:v "42cf5de4-2c64-48fc-a4d8-9e74066c36a3" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Turbidity" ] ; 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 "Spectrophotometer" ] ] ; ( 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 "C74723" ] ; fhir:display [ fhir:v "Turbidity" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-202" ] ] ) ; ( fhir:goalId [ fhir:v "2897e150-8465-48c7-9269-1cda86dc3075" ] ) ] [ fhir:id [ fhir:v "c552eee7-4dca-4a01-b291-5044d5132cc9" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Smell and taste" ] ; 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 "Smell" ] ] ; ( 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 "C139027" ] ; fhir:display [ fhir:v "Odor" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-203" ] ] ) ; ( fhir:goalId [ fhir:v "9c86ccba-a210-4ce5-9a23-b145d9f123c6" ] ) ] [ fhir:id [ fhir:v "b33b402a-0dc7-4953-a7b8-aa2efeb8434f" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Total hardness" ] ; 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 "C134264" ] ; fhir:display [ fhir:v "Hardness" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-204" ] ] ) ; ( fhir:goalId [ fhir:v "de0f0d85-5617-4b07-98fc-9976b2dbf216" ] ) ] ) . # <urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519> a fhir:Organization ; fhir:id [ fhir:v "49438799-e286-432c-b8d8-68ac77e7f519"] ; # 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_49438799-e286-432c-b8d8-68ac77e7f519\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 49438799-e286-432c-b8d8-68ac77e7f519</b></p><a name=\"49438799-e286-432c-b8d8-68ac77e7f519\"> </a><a name=\"hc49438799-e286-432c-b8d8-68ac77e7f519\"> </a><a name=\"49438799-e286-432c-b8d8-68ac77e7f519-en-US\"> </a><p><b>identifier</b>: DUNS/143265625</p><p><b>name</b>: J. Jones Research</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>J. Jones Research, 123 Broad Way, New York, NY, United States</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 "143265625" ] ] ) ; # fhir:name [ fhir:v "J. Jones Research"] ; # fhir:contact ( [ fhir:address [ fhir:type [ fhir:v "postal" ] ; fhir:text [ fhir:v "J. Jones Research, 123 Broad Way, New York, NY, United States" ] ; ( fhir:line [ fhir:v "123 Broad Way" ] ) ; fhir:city [ fhir:v "New York" ] ; fhir:state [ fhir:v "NY" ] ; fhir:postalCode [ fhir:v "00062" ] ; 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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