Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

: 7cdbb042-9275-4599-a1fe-08877846bf94 - TTL Representation

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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 "7cdbb042-9275-4599-a1fe-08877846bf94"] ; # 
  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:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version"^^xsd:anyURI ] ;
fhir:value [ fhir:v "0.1.24" ]     ] ) ;
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:uuid:813b4312-8b6d-42cc-9b8c-8bb6463388cc" ]
  ] ; # 
  fhir:type [ fhir:v "document"] ; # 
  fhir:timestamp [ fhir:v "2024-01-01T19:42:35.255Z"^^xsd:dateTime] ; # 
  fhir:entry ( [
fhir:fullUrl [ fhir:v "urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a> )
  ] ) . # 

<urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4> a fhir:Composition ;
  fhir:id [ fhir:v "4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><p><b>Generated Narrative: Composition</b><a name=\"4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><a name=\"hc4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Composition &quot;4bd1ed57-852b-42be-a9b0-355f8a2aa7d4&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-sp4151.html\">eCTD Specification Composition</a></p></div><p><b>identifier</b>: CochinealSpecificationComposition</p><p><b>status</b>: final</p><p><b>type</b>: Quality Specification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-comp-section-types.html\">Code System PQCMC Comp Section Types</a>#SP4151)</span></p><p><b>date</b>: 2024-01-01 19:42:35+0000</p><p><b>author</b>: See on this page: urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a</p><p><b>title</b>: Cochineal specification Composition Example</p></div>"
  ] ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "CochinealSpecificationComposition" ]
  ] ) ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SP4151" ] ;
fhir:display [ fhir:v "Quality Specification" ]     ] )
  ] ; # 
  fhir:date [ fhir:v "2024-01-01T19:42:35.254Z"^^xsd:dateTime] ; # 
  fhir:author ( [
fhir:reference [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a" ]
  ] ) ; # 
  fhir:title [ fhir:v "Cochineal specification Composition Example"] ; # 
  fhir:section ( [
fhir:title [ fhir:v "32P40" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"^^xsd:anyURI ] ;
fhir:code [ fhir:v "32P40" ] ;
fhir:display [ fhir:v "Product Control of Excipients" ]       ] )     ] ;
    ( fhir:entry [
fhir:reference [ fhir:v "urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e" ]     ] )
  ] ) . # 

<urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e> a fhir:PlanDefinition ;
  fhir:id [ fhir:v "37bf5cc0-33bf-478b-b84e-ccb35143ef6e"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </a><p><b>Generated Narrative: PlanDefinition</b><a name=\"37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </a><a name=\"hc37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition &quot;37bf5cc0-33bf-478b-b84e-ccb35143ef6e&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-quality-specification.html\">Quality Specification</a></p></div><p><b>Specification Type</b>: Raw Materials/Excipients/Intermediates/Reagents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C133931)</span></p><p><b>identifier</b>: CochinealSpecification</p><p><b>version</b>: 1.0</p><p><b>title</b>: Cochineal specification Example</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48660 &quot;Not Applicable&quot;)</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf</p><p><b>date</b>: 2023-12-01</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>e900181a-876c-4ed6-ac96-d5a73c3d6767</blockquote><p><b>description</b>: White Solid <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>White solid <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48793 &quot;EQ&quot;)</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c</blockquote><p><b>description</b>: IR spectrum conforms to reference standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>IR spectrum conforms to reference standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48793 &quot;EQ&quot;)</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>1f476689-f440-4a77-9e9c-0615af3571eb</blockquote><p><b>description</b>: pH 3.4-4.3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>3.4-4.3 [pH]</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>9c0d2619-4505-4e6b-a801-bc30f84bc3e2</blockquote><p><b>description</b>: residue &lt;= 0.21% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.21 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>fc230a97-fd1a-4017-8603-822c5430a217</blockquote><p><b>description</b>: Formaldehyde NMT 1.5% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>1.5 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>8d6688e0-7412-4d64-afe8-b73d8aec596e</blockquote><p><b>description</b>: Impurity C NMT 2% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>f8e8343d-a37d-4b91-916b-f58d6947dc9c</blockquote><p><b>description</b>: Unspecified Impurity NMT 0.10 % w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.1 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>be7abaa1-0769-4560-af76-326e07d1df9a</blockquote><p><b>description</b>: Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.7 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>cfdd469d-020b-4047-946f-f513d58f007f</blockquote><p><b>description</b>: Total Unidentified Impurities NMT 0.3% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.3 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>c5eea380-416f-4d19-a21e-c021f3c7c543</blockquote><p><b>description</b>: RRT 2.2 NMT 0.10% w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.1 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>41e19fa2-f568-443e-8bc1-6b0a6dca9d0c</blockquote><p><b>description</b>: RRT 2.4 NMT 0.10% w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.1 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>e493cb3d-45b6-4463-b9b6-e588c51e032c</blockquote><p><b>description</b>: RRT 3.41 NMT 0.10% w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.2 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>linkId</b>: b9359ce8-73f3-45c5-9674-98d850053aa2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Appearance</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 &quot;Proprietary&quot;)</span></p><p><b>reason</b>: Organoleptic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC6)</span>, Description/Appearance <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#SUBC20)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-101</td></tr></table><p><b>goalId</b>: e900181a-876c-4ed6-ac96-d5a73c3d6767</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>linkId</b>: 443ed163-7a7b-4d48-9462-be5532158411</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Identification</p><p><b>code</b>: FTIR <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 &quot;Proprietary&quot;)</span></p><p><b>reason</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC7)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-102</td></tr></table><p><b>goalId</b>: 21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>linkId</b>: 058193ee-dd86-4c63-9f47-7b0608abbca4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: pH</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 &quot;Proprietary&quot;)</span></p><p><b>reason</b>: pH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC23)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-103</td></tr></table><p><b>goalId</b>: 1f476689-f440-4a77-9e9c-0615af3571eb</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>linkId</b>: 940c8db4-9ed1-416e-84ec-9f9e143be8ab</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Residue on Ignition</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96102 &quot;Compendial&quot;)</span></p><p><b>reason</b>: Residue on Ignition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC38)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>USP &lt;281&gt;</td></tr></table><p><b>goalId</b>: 9c0d2619-4505-4e6b-a801-bc30f84bc3e2</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 5</p><p><b>linkId</b>: 9fca0a37-6d10-4273-a966-c026ab6eb07d</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Impurities</p><p><b>code</b>: FTIR <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 &quot;Proprietary&quot;)</span></p><p><b>reason</b>: Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC53)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-104</td></tr></table><p><b>goalId</b>: fc230a97-fd1a-4017-8603-822c5430a217, 8d6688e0-7412-4d64-afe8-b73d8aec596e, f8e8343d-a37d-4b91-916b-f58d6947dc9c, be7abaa1-0769-4560-af76-326e07d1df9a, cfdd469d-020b-4047-946f-f513d58f007f</p><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 5.1</p><p><b>title</b>: Unidentified Impurities</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C133931" ] ;
fhir:display [ fhir:v "Raw Materials/Excipients/Intermediates/Reagents" ]       ] )     ]
  ] ) ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "CochinealSpecification" ]
  ] ) ; # 
  fhir:version [ fhir:v "1.0"] ; # 
  fhir:title [ fhir:v "Cochineal specification Example"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/plan-definition-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "workflow-definition" ] ;
fhir:display [ fhir:v "Workflow Definition" ]     ] [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48660" ] ;
fhir:display [ fhir:v "Not Applicable" ]     ] )
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:subject [
a fhir:Reference ;
fhir:reference [ fhir:v "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf" ]
  ] ; # 
  fhir:date [ fhir:v "2023-12-01"^^xsd:date] ; # 
  fhir:goal ( [
fhir:id [ fhir:v "e900181a-876c-4ed6-ac96-d5a73c3d6767" ] ;
fhir:description [
fhir:text [ fhir:v "White Solid" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48793" ] ;
fhir:display [ fhir:v "EQ" ]         ] ) ;
fhir:text [ fhir:v "White solid" ]       ]     ] )
  ] [
fhir:id [ fhir:v "21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c" ] ;
fhir:description [
fhir:text [ fhir:v "IR spectrum conforms to reference standard" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48793" ] ;
fhir:display [ fhir:v "EQ" ]         ] ) ;
fhir:text [ fhir:v "IR spectrum conforms to reference standard" ]       ]     ] )
  ] [
fhir:id [ fhir:v "1f476689-f440-4a77-9e9c-0615af3571eb" ] ;
fhir:description [
fhir:text [ fhir:v "pH 3.4-4.3" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Range ;
fhir:low [
          ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
              ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61583" ] ;
fhir:display [ fhir:v "NLT (not less than)" ]               ] )             ]           ] ) ;
fhir:value [ fhir:v "3.4"^^xsd:decimal ] ;
fhir:unit [ fhir:v "[pH]" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C45997" ]         ] ;
fhir:high [
          ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
              ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61586" ] ;
fhir:display [ fhir:v "NMT (not more than)" ]               ] )             ]           ] ) ;
fhir:value [ fhir:v "4.3"^^xsd:decimal ] ;
fhir:unit [ fhir:v "[pH]" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C45997" ]         ]       ]     ] )
  ] [
fhir:id [ fhir:v "9c0d2619-4505-4e6b-a801-bc30f84bc3e2" ] ;
fhir:description [
fhir:text [ fhir:v "residue <= 0.21%" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
            ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61586" ] ;
fhir:display [ fhir:v "NMT (not more than)" ]             ] )           ]         ] ) ;
fhir:value [ fhir:v "0.21"^^xsd:decimal ] ;
fhir:unit [ fhir:v "%" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48570" ]       ]     ] )
  ] [
fhir:id [ fhir:v "fc230a97-fd1a-4017-8603-822c5430a217" ] ;
fhir:description [
fhir:text [ fhir:v "Formaldehyde NMT 1.5%" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
            ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61586" ] ;
fhir:display [ fhir:v "NMT (not more than)" ]             ] )           ]         ] ) ;
fhir:value [ fhir:v "1.5"^^xsd:decimal ] ;
fhir:unit [ fhir:v "%" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48570" ]       ]     ] )
  ] [
fhir:id [ fhir:v "8d6688e0-7412-4d64-afe8-b73d8aec596e" ] ;
fhir:description [
fhir:text [ fhir:v "Impurity C NMT 2%" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
            ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61586" ] ;
fhir:display [ fhir:v "NMT (not more than)" ]             ] )           ]         ] ) ;
fhir:value [ fhir:v "2"^^xsd:decimal ] ;
fhir:unit [ fhir:v "%" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48570" ]       ]     ] )
  ] [
fhir:id [ fhir:v "f8e8343d-a37d-4b91-916b-f58d6947dc9c" ] ;
fhir:description [
fhir:text [ fhir:v "Unspecified Impurity NMT 0.10 % w/w" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
            ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61586" ] ;
fhir:display [ fhir:v "NMT (not more than)" ]             ] )           ]         ] ) ;
fhir:value [ fhir:v "0.1"^^xsd:decimal ] ;
fhir:unit [ fhir:v "%{WeightToWeight}" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48528" ]       ]     ] )
  ] [
fhir:id [ fhir:v "be7abaa1-0769-4560-af76-326e07d1df9a" ] ;
fhir:description [
fhir:text [ fhir:v "Total Impurities" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
            ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61586" ] ;
fhir:display [ fhir:v "NMT (not more than)" ]             ] )           ]         ] ) ;
fhir:value [ fhir:v "0.7"^^xsd:decimal ] ;
fhir:unit [ fhir:v "%" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48570" ]       ]     ] )
  ] [
fhir:id [ fhir:v "cfdd469d-020b-4047-946f-f513d58f007f" ] ;
fhir:description [
fhir:text [ fhir:v "Total Unidentified Impurities NMT 0.3%" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
            ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61586" ] ;
fhir:display [ fhir:v "NMT (not more than)" ]             ] )           ]         ] ) ;
fhir:value [ fhir:v "0.3"^^xsd:decimal ] ;
fhir:unit [ fhir:v "%" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48570" ]       ]     ] )
  ] [
fhir:id [ fhir:v "c5eea380-416f-4d19-a21e-c021f3c7c543" ] ;
fhir:description [
fhir:text [ fhir:v "RRT 2.2 NMT 0.10% w/w" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
            ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61586" ] ;
fhir:display [ fhir:v "NMT (not more than)" ]             ] )           ]         ] ) ;
fhir:value [ fhir:v "0.1"^^xsd:decimal ] ;
fhir:unit [ fhir:v "%{WeightToWeight}" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48528" ]       ]     ] )
  ] [
fhir:id [ fhir:v "41e19fa2-f568-443e-8bc1-6b0a6dca9d0c" ] ;
fhir:description [
fhir:text [ fhir:v "RRT 2.4 NMT 0.10% w/w" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
            ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61586" ] ;
fhir:display [ fhir:v "NMT (not more than)" ]             ] )           ]         ] ) ;
fhir:value [ fhir:v "0.1"^^xsd:decimal ] ;
fhir:unit [ fhir:v "%{WeightToWeight}" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48528" ]       ]     ] )
  ] [
fhir:id [ fhir:v "e493cb3d-45b6-4463-b9b6-e588c51e032c" ] ;
fhir:description [
fhir:text [ fhir:v "RRT 3.41 NMT 0.10% w/w" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
            ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C61586" ] ;
fhir:display [ fhir:v "NMT (not more than)" ]             ] )           ]         ] ) ;
fhir:value [ fhir:v "0.2"^^xsd:decimal ] ;
fhir:unit [ fhir:v "%{WeightToWeight}" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48528" ]       ]     ] )
  ] ) ; # 
  fhir:action ( [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:decimal ]     ] ) ;
fhir:linkId [ fhir:v "b9359ce8-73f3-45c5-9674-98d850053aa2" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Appearance" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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:integer ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "TC6" ] ;
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:integer ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SUBC20" ] ;
fhir:display [ fhir:v "Description/Appearance" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-101" ]     ] ) ;
    ( fhir:goalId [ fhir:v "e900181a-876c-4ed6-ac96-d5a73c3d6767" ] )
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2"^^xsd:decimal ]     ] ) ;
fhir:linkId [ fhir:v "443ed163-7a7b-4d48-9462-be5532158411" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Identification" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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:integer ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "TC7" ] ;
fhir:display [ fhir:v "Identification" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-102" ]     ] ) ;
    ( fhir:goalId [ fhir:v "21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c" ] )
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "3"^^xsd:decimal ]     ] ) ;
fhir:linkId [ fhir:v "058193ee-dd86-4c63-9f47-7b0608abbca4" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "pH" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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:integer ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "TC23" ] ;
fhir:display [ fhir:v "pH" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-103" ]     ] ) ;
    ( fhir:goalId [ fhir:v "1f476689-f440-4a77-9e9c-0615af3571eb" ] )
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "4"^^xsd:decimal ]     ] ) ;
fhir:linkId [ fhir:v "940c8db4-9ed1-416e-84ec-9f9e143be8ab" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Residue on Ignition" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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:integer ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "TC38" ] ;
fhir:display [ fhir:v "Residue on Ignition" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "USP <281>" ]     ] ) ;
    ( fhir:goalId [ fhir:v "9c0d2619-4505-4e6b-a801-bc30f84bc3e2" ] )
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "5"^^xsd:decimal ]     ] ) ;
fhir:linkId [ fhir:v "9fca0a37-6d10-4273-a966-c026ab6eb07d" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Impurities" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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:integer ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "TC53" ] ;
fhir:display [ fhir:v "Impurity" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-104" ]     ] ) ;
    ( fhir:goalId [ fhir:v "fc230a97-fd1a-4017-8603-822c5430a217" ] [ fhir:v "8d6688e0-7412-4d64-afe8-b73d8aec596e" ] [ fhir:v "f8e8343d-a37d-4b91-916b-f58d6947dc9c" ] [ fhir:v "be7abaa1-0769-4560-af76-326e07d1df9a" ] [ fhir:v "cfdd469d-020b-4047-946f-f513d58f007f" ] ) ;
    ( fhir:action [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "5.1"^^xsd:decimal ]       ] ) ;
fhir:title [ fhir:v "Unidentified Impurities" ] ;
      ( fhir:action [
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "5.11"^^xsd:decimal ]         ] ) ;
fhir:prefix [ fhir:v "RRT" ] ;
fhir:title [ fhir:v "2.2" ] ;
        ( fhir:goalId [ fhir:v "c5eea380-416f-4d19-a21e-c021f3c7c543" ] )       ] [
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "5.12"^^xsd:decimal ]         ] ) ;
fhir:prefix [ fhir:v "RRT" ] ;
fhir:title [ fhir:v "2.4" ] ;
        ( fhir:goalId [ fhir:v "41e19fa2-f568-443e-8bc1-6b0a6dca9d0c" ] )       ] [
        ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "5.13"^^xsd:decimal ]         ] ) ;
fhir:prefix [ fhir:v "RRT" ] ;
fhir:title [ fhir:v "3.41" ] ;
        ( fhir:goalId [ fhir:v "e493cb3d-45b6-4463-b9b6-e588c51e032c" ] )       ] )     ] )
  ] ) . # 

<urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf> a fhir:SubstanceDefinition ;
  fhir:id [ fhir:v "278736ef-2ddf-49e4-895c-3a9f34db36cf"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><a name=\"hc278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition &quot;278736ef-2ddf-49e4-895c-3a9f34db36cf&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Cochineal</p><p><b>classification</b>: Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>grade</b>: Company Standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134009)</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>TZ8Z31B35M <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#TZ8Z31B35M)</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>Cochineal</td><td>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C203355)</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>Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></td><td>Dactylopius <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>cochineal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>Turkey <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#TUR)</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "Cochineal" ]
  ] ) ; # 
  fhir:classification ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48807" ] ;
fhir:display [ fhir:v "Chemical" ]     ] )
  ] ) ; # 
  fhir:grade ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134009" ] ;
fhir:display [ fhir:v "Company Standard" ]     ] )
  ] ) ; # 
  fhir:code ( [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "TZ8Z31B35M" ]       ] )     ]
  ] ) ; # 
  fhir:name ( [
fhir:name [ fhir:v "Cochineal" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48807" ] ;
fhir:display [ fhir:v "Chemical" ]       ] )     ] ;
fhir:genus [
fhir:text [ fhir:v "Dactylopius" ]     ] ;
fhir:species [
fhir:text [ fhir:v "cochineal" ]     ] ;
    ( fhir:countryOfOrigin [
      ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "TUR" ] ;
fhir:display [ fhir:v "Turkey" ]       ] )     ] )
  ] . # 

<urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a> a fhir:Organization ;
  fhir:id [ fhir:v "4f3e9af1-306b-4fad-bf04-7881400b266a"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-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><b>Generated Narrative: Organization</b><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization &quot;4f3e9af1-306b-4fad-bf04-7881400b266a&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-sponsor-organization.html\">Sponsor Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^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: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" ]     ]
  ] ) . #