Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
<!-- Substance Stability Study -->
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-drug-stability-pq-ex2-sub"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq"/>
</meta>
<type value="collection"/>
<!-- Section 11 - Stability Study - Results -->
<entry>
<fullUrl value="urn:uuid:54c8e8dc-9a19-0dc2-910e-d5a05d6ba003"/>
<resource>
<DiagnosticReport>
<id value="studyResultsReport"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DiagnosticReport</b><a name="studyResultsReport"> </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 DiagnosticReport "studyResultsReport" </p></div><p><b>Triggered by</b>: <a href="#PlanDefinition_c3973835-10ca-0796-0a26-aa8afafc9c5b">See above (PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b)</a></p><p><b>Extension - Statistical Model PQ</b>: information about statistical model utilized to interpret stability study results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>Extension - Container Orientation PQ</b>: Horizontal <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-containerOrientation-local-pq.html">CodeSystem - Container Orientation</a>#horizontal "horizontal")</span></p><p><b>identifier</b>: id: PLO555</p><p><b>status</b>: final</p><p><b>code</b>: Stability Study Report <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-reportType-local-pq.html">CodeSystem - Report Type</a>#Stability Study Report)</span></p><p><b>effective</b>: 2019-09-08</p><p><b>performer</b>: <a href="#Organization_6049d921-9935-90b7-4efc-894a66483c00">See above (Organization/6049d921-9935-90b7-4efc-894a66483c00)</a></p><p><b>result</b>: </p><ul><li><a href="#Observation_588a6787-0454-55ef-0b8a-4c8941b6976c">See above (Observation/588a6787-0454-55ef-0b8a-4c8941b6976c)</a></li><li><a href="#Observation_930c7f69-2546-7148-2069-b3be3a755edf">See above (Observation/930c7f69-2546-7148-2069-b3be3a755edf)</a></li><li><a href="#Observation_8070745c-30c4-a52e-41fd-600a913578d4">See above (Observation/8070745c-30c4-a52e-41fd-600a913578d4)</a></li><li><a href="#Observation_f16113fe-27e7-0aa2-6787-9415f5051900">See above (Observation/f16113fe-27e7-0aa2-6787-9415f5051900)</a></li><li><a href="#Observation_1b25eb25-9149-02f6-9676-c87f90c64904">See above (Observation/1b25eb25-9149-02f6-9676-c87f90c64904)</a></li><li><a href="#Observation_004ed877-7729-834e-3b6b-a2cf4bdb2377">See above (Observation/004ed877-7729-834e-3b6b-a2cf4bdb2377)</a></li><li><a href="#Observation_f958e1e9-6023-4e39-2ffe-a9c8f135a2dd">See above (Observation/f958e1e9-6023-4e39-2ffe-a9c8f135a2dd)</a></li></ul><p><b>conclusion</b>: The samples have been assessed and the conclusion is...</p></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- PlanDefinition/stabilityStudyProtocol -->
<reference
value="PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq">
<valueCodeableConcept>
<!-- Want to use studyDesign, but problem is that this is CodeableConcept, which allows text. However when you use text, you then
have no place to put a context. Ideally this would be a code/code pair.
Code says "statistical model", code (or text) then says what it is -->
<text
value="information about statistical model utilized to interpret stability study results"/>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-containerOrientation-local-pq"/>
<code value="horizontal"/>
<display value="horizontal"/>
</coding>
<text value="Horizontal"/>
</valueCodeableConcept>
</extension>
<identifier>
<system value="https://eudract.europa.eu/example/identifier"/>
<value value="PLO555"/>
</identifier>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq"/>
<code value="Stability Study Report"/>
<display value="Stability Study Report"/>
</coding>
</code>
<effectiveDateTime value="2019-09-08">
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-timePointDescription-local-pq"/>
<code value="Delayed Start Code"/>
<display value="Delayed Start Code"/>
</coding>
<text value="Refrigerated delayed testing"/>
</valueCodeableConcept>
</extension>
</effectiveDateTime>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/6049d921-9935-90b7-4efc-894a66483c00"/>
</performer>
<result>
<!-- Observation/LongTerm30C-initial-1 -->
<reference
value="Observation/588a6787-0454-55ef-0b8a-4c8941b6976c"/>
</result>
<result>
<!-- Observation/LongTerm30C-Initial-2 -->
<reference
value="Observation/930c7f69-2546-7148-2069-b3be3a755edf"/>
</result>
<result>
<!-- Observation/LongTerm30C-Initial-3 -->
<reference
value="Observation/8070745c-30c4-a52e-41fd-600a913578d4"/>
</result>
<result>
<!-- Observation/LongTerm30C-18m -->
<reference
value="Observation/f16113fe-27e7-0aa2-6787-9415f5051900"/>
</result>
<result>
<!-- Observation/LongTerm30C-18m-2 -->
<reference
value="Observation/1b25eb25-9149-02f6-9676-c87f90c64904"/>
</result>
<result>
<!-- Observation/LongTerm30C-18m-3 -->
<reference
value="Observation/004ed877-7729-834e-3b6b-a2cf4bdb2377"/>
</result>
<result>
<!-- Observation/Accelerated40C-3m -->
<reference
value="Observation/f958e1e9-6023-4e39-2ffe-a9c8f135a2dd"/>
</result>
<conclusion
value="The samples have been assessed and the conclusion is..."/>
</DiagnosticReport>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:c3973835-10ca-0796-0a26-aa8afafc9c5b"/>
<!-- Section 11 - Stability Study - Protocol -->
<resource>
<PlanDefinition>
<!-- stabilityStudyProtocol -->
<id value="c3973835-10ca-0796-0a26-aa8afafc9c5b"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="c3973835-10ca-0796-0a26-aa8afafc9c5b"> </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 "c3973835-10ca-0796-0a26-aa8afafc9c5b" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b</code></p><p><b>title</b>: Stability Monitoring Program</p><p><b>type</b>: Stability Study Protocol <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (planType#1244588)</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href="#SubstanceDefinition_2e3a85b5-790a-a108-3627-edf0ec6f1210">See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)</a></p><p><b>description</b>: Description of the study study plan which includes tests, time points, storage conditions, method</p><blockquote><p><b>action</b></p><p><b>title</b>: Stability Test Protocol for Long-term and Accelerated Storage of Stelbatolol</p><blockquote><p><b>action</b></p><p><b>title</b>: Long-Term</p><p><b>description</b>: 30°C/65% RH</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Accelerated</p><p><b>description</b>: 40°C/75% RH</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>
</text>
<!-- http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b -->
<url
value="http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b"/>
<title value="Stability Monitoring Program"/>
<!-- Added type (8/22/2023) -->
<type>
<coding>
<system value="http://example.org/fhir/code/planType"/>
<code value="1244588"/>
<display value="Stability Study Protocol"/>
</coding>
</type>
<status value="active"/>
<subjectReference>
<!-- SubstanceDefinition/substance1 -->
<reference
value="SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210"/>
</subjectReference>
<!-- unclear if want subject here, because it may apply to different ones -->
<!-- subjectCanonical value="MedicinalProductDefinition/product"/ -->
<!-- this isn't followed at the moment, if it isnt in the file -->
<description
value="Description of the study study plan which includes tests, time points, storage conditions, method"/>
<!-- end of accelerated -->
<action>
<title
value="Stability Test Protocol for Long-term and Accelerated Storage of Stelbatolol"/>
<action>
<!-- TODO add codes here for the different levels? -->
<title value="Long-Term"/>
<description value="30°C/65% RH"/>
<action>
<!-- 0 months -->
<title value="Initial"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="0"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="0"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<!-- the categories to do at this step -->
<title value="XY"/>
<!-- Long term -->
<!-- ActivityDefinition/activityLongTerm30XY-Initial -->
<definitionCanonical
value="ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"/>
</action>
</action>
<action>
<!-- 3 months -->
<title value="3"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="3"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="3"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityLongTerm30X-3 -->
<definitionCanonical
value="ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e"/>
</action>
</action>
<action>
<!-- 6 months -->
<title value="6"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="6"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="6"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityLongTerm30X-6 -->
<definitionCanonical
value="ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3"/>
</action>
</action>
<action>
<!-- 9 months -->
<title value="9"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="9"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="9"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityLongTerm30X-9 -->
<definitionCanonical
value="ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201"/>
</action>
</action>
<action>
<!-- 12 months -->
<title value="12"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="12"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="12"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityLongTerm30X-12 -->
<definitionCanonical
value="ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"/>
</action>
</action>
<action>
<!-- 18 months -->
<title value="18"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="18"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="18"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityLongTerm30X-18 -->
<definitionCanonical
value="ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"/>
</action>
</action>
<action>
<!-- 24 months -->
<title value="24"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="24"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="24"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityLongTerm30X-24 -->
<definitionCanonical
value="ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"/>
</action>
</action>
<!-- 36 months -->
<action>
<title value="36"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="36"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="36"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="(X)"/>
<requiredBehavior value="could"/>
<!-- ActivityDefinition/activityLongTerm30X-36 -->
<definitionCanonical
value="ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149"/>
</action>
</action>
</action>
<!-- end of long term -->
<action>
<title value="Accelerated"/>
<description value="40°C/75% RH"/>
<action>
<!-- 0 months -->
<title value="Initial"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="0"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="0"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<!-- second category at this step -->
<title value="XY"/>
<!-- ActivityDefinition/activityAccelerated40XY-Initial -->
<definitionCanonical
value="ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495"/>
</action>
</action>
<action>
<!-- 3 months -->
<title value="3"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="3"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="3"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityAccelerated40X-3 -->
<definitionCanonical
value="ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"/>
</action>
</action>
<action>
<!-- 6 months -->
<title value="6"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="6"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="6"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityAccelerated40X-6 -->
<definitionCanonical
value="ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817"/>
</action>
</action>
<action>
<!-- 9 months -->
<title value="9"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="9"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="9"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<!-- none -->
<title value="-"/>
</action>
</action>
<action>
<!-- 12 months -->
<title value="12"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="12"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="12"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<!-- none -->
<title value="-"/>
</action>
</action>
<action>
<!-- 18 months -->
<title value="18"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="18"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="18"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<!-- none -->
<title value="-"/>
</action>
</action>
<action>
<!-- 24 months -->
<title value="24"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="24"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="24"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<!-- none -->
<title value="-"/>
</action>
</action>
<!-- 36 months -->
<action>
<title value="36"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="36"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="36"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="-"/>
</action>
</action>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<!-- Long term tests -->
<entry>
<fullUrl value="urn:uuid:643d8b44-71f4-2b58-07e8-51c22b294b25"/>
<resource>
<SpecimenDefinition>
<!-- specimenDefStoredAt30 -->
<id value="643d8b44-71f4-2b58-07e8-51c22b294b25"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SpecimenDefinition</b><a name="643d8b44-71f4-2b58-07e8-51c22b294b25"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SpecimenDefinition "643d8b44-71f4-2b58-07e8-51c22b294b25" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25</code></p><p><b>status</b>: active</p><blockquote><p><b>typeTested</b></p><p><b>preference</b>: preferred</p><h3>Handlings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Instruction</b></td></tr><tr><td style="display: none">*</td><td>30°C/65% RH</td></tr></table></blockquote></div>
</text>
<!-- <meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq"/>
</meta> -->
<!-- http://example-server.com/fhir/SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25 -->
<url
value="http://example-server.com/fhir/SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25"/>
<status value="active"/>
<typeTested>
<preference value="preferred"/>
<!-- easier than temp range? which doesnt have humidity -->
<handling>
<instruction value="30°C/65% RH"/>
</handling>
</typeTested>
</SpecimenDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:10d7b693-7a0e-2f71-9a10-642e5a0a5d42"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm30XY-Initial -->
<id value="10d7b693-7a0e-2f71-9a10-642e5a0a5d42"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="10d7b693-7a0e-2f71-9a10-642e5a0a5d42"> </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 ActivityDefinition "10d7b693-7a0e-2f71-9a10-642e5a0a5d42" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42</code></p><p><b>title</b>: Long-term - 30°C/65% RH - XY</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a>, <a href="http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e">http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"/>
<title value="Long-term - 30°C/65% RH - XY"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm30X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"/>
<!-- ObservationDefinition/longTerm30Y -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:480a61f8-14b3-233e-8e5f-7f0db9696a1e"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm30X-3 -->
<id value="480a61f8-14b3-233e-8e5f-7f0db9696a1e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="480a61f8-14b3-233e-8e5f-7f0db9696a1e"> </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 ActivityDefinition "480a61f8-14b3-233e-8e5f-7f0db9696a1e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e -->
<url
value="http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e"/>
<title value="Long-term - 30°C/65% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm30X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:bee486c4-6ab5-6293-4114-d4be24f303d3"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm30X-6 -->
<id value="bee486c4-6ab5-6293-4114-d4be24f303d3"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="bee486c4-6ab5-6293-4114-d4be24f303d3"> </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 ActivityDefinition "bee486c4-6ab5-6293-4114-d4be24f303d3" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3"/>
<title value="Long-term - 30°C/65% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm30X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:99893d3c-520c-8d7b-6d73-f46b1a662201"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm30X-9 -->
<id value="99893d3c-520c-8d7b-6d73-f46b1a662201"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="99893d3c-520c-8d7b-6d73-f46b1a662201"> </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 ActivityDefinition "99893d3c-520c-8d7b-6d73-f46b1a662201" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201"/>
<title value="Long-term - 30°C/65% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm30X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm30X-12 -->
<id value="b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"> </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 ActivityDefinition "b3254b8e-6fc3-88d3-7d38-0afcf13c4f67" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"/>
<title value="Long-term - 30°C/65% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm30X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:c9b53a46-2f61-7b3f-5780-5f5c79a47f12"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm30X-18 -->
<id value="c9b53a46-2f61-7b3f-5780-5f5c79a47f12"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="c9b53a46-2f61-7b3f-5780-5f5c79a47f12"> </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 ActivityDefinition "c9b53a46-2f61-7b3f-5780-5f5c79a47f12" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"/>
<title value="Long-term - 30°C/65% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm30X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm30X-24 -->
<id value="d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"> </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 ActivityDefinition "d6f7de9d-57a5-6a2c-1c2f-0d65718860f2" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"/>
<title value="Long-term - 30°C/65% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm30X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:75073965-82eb-407d-34cf-3a7767a38149"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm30X-36 -->
<id value="75073965-82eb-407d-34cf-3a7767a38149"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="75073965-82eb-407d-34cf-3a7767a38149"> </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 ActivityDefinition "75073965-82eb-407d-34cf-3a7767a38149" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149</code></p><p><b>title</b>: Long-term - 30°C/65% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba">http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149"/>
<title value="Long-term - 30°C/65% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm30X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:18762cff-9e29-6e71-1184-e9202fee8cba"/>
<!-- can have others -->
<resource>
<ObservationDefinition>
<!-- longTerm30X -->
<id value="18762cff-9e29-6e71-1184-e9202fee8cba"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="18762cff-9e29-6e71-1184-e9202fee8cba"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "18762cff-9e29-6e71-1184-e9202fee8cba" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba</code></p><p><b>title</b>: X</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'X' at 30°C/65% RH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_643d8b44-71f4-2b58-07e8-51c22b294b25">See above (SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25)</a></p><p><b>hasMember</b>: </p><ul><li><a href="#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></li><li><a href="#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></li><li><a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></li></ul></div>
</text>
<!-- <meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta> -->
<!-- http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba -->
<url
value="http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba"/>
<title value="X"/>
<status value="active"/>
<code>
<text value="Battery of tests 'X' at 30°C/65% RH"/>
</code>
<specimen>
<!-- SpecimenDefinition/specimenDefStoredAt30 -->
<reference
value="SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
</hasMember>
<hasMember>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"/>
</hasMember>
<hasMember>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
<resource>
<ObservationDefinition>
<!-- Description -->
<id value="559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="559ffdc3-349b-a4a3-a651-ce2715f08d69"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "559ffdc3-349b-a4a3-a651-ce2715f08d69" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
<title value="Description"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="A white to brown powder"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:7943795a-2abe-666f-545f-133e23b97119"/>
<resource>
<ObservationDefinition>
<!-- Assay -->
<id value="7943795a-2abe-666f-545f-133e23b97119"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="7943795a-2abe-666f-545f-133e23b97119"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "7943795a-2abe-666f-545f-133e23b97119" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</code></p><p><b>title</b>: Assay (% w/w) (Mean)</p><p><b>status</b>: active</p><p><b>code</b>: Assay (% w/w) (Mean) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY "Assay")</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>98-102 % w/w</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"/>
<title value="Assay (% w/w) (Mean)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay (% w/w) (Mean)"/>
</code>
<qualifiedValue>
<range>
<low>
<value value="98"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</low>
<high>
<value value="102"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:73d9d304-a0b8-31b6-1165-346563b9305e"/>
<resource>
<ObservationDefinition>
<!-- Impurities -->
<id value="73d9d304-a0b8-31b6-1165-346563b9305e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="73d9d304-a0b8-31b6-1165-346563b9305e"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "73d9d304-a0b8-31b6-1165-346563b9305e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</code></p><p><b>title</b>: Drug-related Impurities Content by LC (% w/w)</p><p><b>status</b>: active</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.52</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.10</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-2.0</p></blockquote><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
<title value="Drug-related Impurities Content by LC (% w/w)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
</code>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="Impurity"/>
</appliesTo>
<range>
<high>
<value value="0.5"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Impurity 2"/>
</appliesTo>
<range>
<high>
<value value="0.52"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Any Unspecified Impurity"/>
</appliesTo>
<range>
<high>
<value value="0.10"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Total Impurities"/>
</appliesTo>
<range>
<high>
<value value="2.0"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<component>
<!-- are expected to have a component that says what impurity this one is -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:31abea79-81da-17f8-9d8c-94e9bb75876e"/>
<!-- can have others -->
<resource>
<ObservationDefinition>
<!-- longTerm30Y -->
<id value="31abea79-81da-17f8-9d8c-94e9bb75876e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="31abea79-81da-17f8-9d8c-94e9bb75876e"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "31abea79-81da-17f8-9d8c-94e9bb75876e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e</code></p><p><b>title</b>: Y</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Y' at 30°C/65% RH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_643d8b44-71f4-2b58-07e8-51c22b294b25">See above (SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25)</a></p><p><b>hasMember</b>: <a href="#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p></div>
</text>
<!-- <meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta> -->
<!-- http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e"/>
<title value="Y"/>
<status value="active"/>
<code>
<text value="Battery of tests 'Y' at 30°C/65% RH"/>
</code>
<specimen>
<!-- SpecimenDefinition/specimenDefStoredAt30 -->
<reference
value="SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:6b96124b-1a44-0b6b-6783-d6c49360230b"/>
<resource>
<ObservationDefinition>
<!-- Identification -->
<id value="6b96124b-1a44-0b6b-6783-d6c49360230b"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="6b96124b-1a44-0b6b-6783-d6c49360230b"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "6b96124b-1a44-0b6b-6783-d6c49360230b" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b -->
<url
value="http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
<title value="Identification"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="Complies"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<!-- Accelerated tests -->
<entry>
<fullUrl value="urn:uuid:306637ec-1041-80e8-8e77-e7ca814253e1"/>
<resource>
<SpecimenDefinition>
<!-- specimenDefStoredAt40 -->
<id value="306637ec-1041-80e8-8e77-e7ca814253e1"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SpecimenDefinition</b><a name="306637ec-1041-80e8-8e77-e7ca814253e1"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SpecimenDefinition "306637ec-1041-80e8-8e77-e7ca814253e1" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1</code></p><p><b>status</b>: active</p><blockquote><p><b>typeTested</b></p><p><b>preference</b>: preferred</p><h3>Handlings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Instruction</b></td></tr><tr><td style="display: none">*</td><td>40°C/75% RH</td></tr></table></blockquote></div>
</text>
<!-- <meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq"/>
</meta> -->
<!-- http://example-server.com/fhir/SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1 -->
<url
value="http://example-server.com/fhir/SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1"/>
<status value="active"/>
<typeTested>
<preference value="preferred"/>
<handling>
<instruction value="40°C/75% RH"/>
</handling>
</typeTested>
</SpecimenDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:1b43a536-3c29-3427-0b93-e35866ef8495"/>
<resource>
<ActivityDefinition>
<!-- activityAccelerated40XY-Initial -->
<id value="1b43a536-3c29-3427-0b93-e35866ef8495"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="1b43a536-3c29-3427-0b93-e35866ef8495"> </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 ActivityDefinition "1b43a536-3c29-3427-0b93-e35866ef8495" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - XY</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc">http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc</a>, <a href="http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6">http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495"/>
<title value="Accelerated - 40°C/70% RH - XY"/>
<status value="active"/>
<!-- ObservationDefinition/accelerated40X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc"/>
<!-- ObservationDefinition/accelerated40Y -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"/>
<resource>
<ActivityDefinition>
<!-- activityAccelerated40X-3 -->
<id value="8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"> </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 ActivityDefinition "8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc">http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"/>
<title value="Accelerated - 40°C/70% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/accelerated40X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:cf2f00df-971f-0bab-8768-4251b1ad0817"/>
<resource>
<ActivityDefinition>
<!-- activityAccelerated40X-6 -->
<id value="cf2f00df-971f-0bab-8768-4251b1ad0817"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="cf2f00df-971f-0bab-8768-4251b1ad0817"> </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 ActivityDefinition "cf2f00df-971f-0bab-8768-4251b1ad0817" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc">http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817"/>
<title value="Accelerated - 40°C/70% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/accelerated40X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:35fa7b97-98d3-35d3-5672-4ab1047d57fc"/>
<!-- can have others -->
<resource>
<ObservationDefinition>
<!-- accelerated40X -->
<id value="35fa7b97-98d3-35d3-5672-4ab1047d57fc"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="35fa7b97-98d3-35d3-5672-4ab1047d57fc"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "35fa7b97-98d3-35d3-5672-4ab1047d57fc" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc</code></p><p><b>title</b>: X</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'X' at 40°C/75% RH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_306637ec-1041-80e8-8e77-e7ca814253e1">See above (SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1)</a></p><p><b>hasMember</b>: </p><ul><li><a href="#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></li><li><a href="#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></li></ul></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc -->
<url
value="http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc"/>
<title value="X"/>
<status value="active"/>
<code>
<text value="Battery of tests 'X' at 40°C/75% RH"/>
</code>
<specimen>
<!-- SpecimenDefinition/specimenDefStoredAt40 -->
<reference
value="SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
</hasMember>
<hasMember>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:accb8802-4223-61e2-8c79-2282e22a2bb6"/>
<!-- can have others -->
<resource>
<ObservationDefinition>
<!-- accelerated40Y -->
<id value="accb8802-4223-61e2-8c79-2282e22a2bb6"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="accb8802-4223-61e2-8c79-2282e22a2bb6"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "accb8802-4223-61e2-8c79-2282e22a2bb6" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6</code></p><p><b>title</b>: Y</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Y' at 40°C/75% RH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_306637ec-1041-80e8-8e77-e7ca814253e1">See above (SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1)</a></p><p><b>hasMember</b>: <a href="#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6"/>
<title value="Y"/>
<status value="active"/>
<code>
<text value="Battery of tests 'Y' at 40°C/75% RH"/>
</code>
<specimen>
<!-- SpecimenDefinition/specimenDefStoredAt40 -->
<reference
value="SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Long Term XY - 18M - on batch 1 -->
<entry>
<fullUrl value="urn:uuid:6a5354bf-602c-99f1-324b-0bb5f7e06cd5"/>
<resource>
<Specimen>
<!-- stabilityInitial-1 -->
<id value="6a5354bf-602c-99f1-324b-0bb5f7e06cd5"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="6a5354bf-602c-99f1-324b-0bb5f7e06cd5"> </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 Specimen "6a5354bf-602c-99f1-324b-0bb5f7e06cd5" </p></div><h3>Collections</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Collected[x]</b></td></tr><tr><td style="display: none">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>
</text>
<!-- when sample first taken, before the timed periods start -->
<collection>
<collectedDateTime value="2020-06"/>
</collection>
<processing>
<description value="No storage"/>
</processing>
<processing>
<description value="25°C/60% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Long Term XYZ - Initial - on batch 1 -->
<entry>
<fullUrl value="urn:uuid:588a6787-0454-55ef-0b8a-4c8941b6976c"/>
<resource>
<Observation>
<!-- LongTerm30C-initial-1 -->
<id value="588a6787-0454-55ef-0b8a-4c8941b6976c"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="588a6787-0454-55ef-0b8a-4c8941b6976c"> </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 Observation "588a6787-0454-55ef-0b8a-4c8941b6976c" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_10d7b693-7a0e-2f71-9a10-642e5a0a5d42">See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href="#Specimen_6a5354bf-602c-99f1-324b-0bb5f7e06cd5">See above (Specimen/6a5354bf-602c-99f1-324b-0bb5f7e06cd5)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm30C-initial-1-Description"> </a></li><li><a name="LongTerm30C-initial-1-Assay"> </a></li><li><a name="LongTerm30C-initial-1-Impurity1"> </a></li><li><a name="LongTerm30C-initial-1-Impurity2"> </a></li><li><a name="LongTerm30C-initial-1-ImpurityUnspecified"> </a></li><li><a name="LongTerm30C-initial-1-ImpurityTotal"> </a></li><li><a name="LongTerm30C-initial-1-Identification"> </a></li></ul><blockquote><p/><p><a name="LongTerm30C-initial-1-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-1-Assay"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.15 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-1-Impurity1"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-1-Impurity2"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-1-ImpurityUnspecified"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.05 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-1-ImpurityTotal"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.8 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-1-Identification"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-Description</b><a name="LongTerm30C-initial-1-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-Impurity1</b><a name="LongTerm30C-initial-1-Impurity1"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.1 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-Impurity2</b><a name="LongTerm30C-initial-1-Impurity2"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.2 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-ImpurityUnspecified</b><a name="LongTerm30C-initial-1-ImpurityUnspecified"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.05 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-ImpurityTotal</b><a name="LongTerm30C-initial-1-ImpurityTotal"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.8 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-Assay</b><a name="LongTerm30C-initial-1-Assay"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.15 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-1-Identification</b><a name="LongTerm30C-initial-1-Identification"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm30C-initial-1-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-1-Impurity1"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.1"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-1-Impurity2"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.2"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-1-ImpurityUnspecified"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.05"/>
<comparator value="<"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-1-ImpurityTotal"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.8"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-1-Assay"/>
<instantiatesReference>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.15"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-1-Identification"/>
<instantiatesReference>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityLongTerm30XY-Initial -->
<reference
value="ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Long-term 25C etc - Initial (XYZ)"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<specimen>
<!-- Specimen/stabilityInitial-1 -->
<reference value="Specimen/6a5354bf-602c-99f1-324b-0bb5f7e06cd5"/>
</specimen>
<hasMember>
<reference value="#LongTerm30C-initial-1-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-1-Assay"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-1-Impurity1"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-1-Impurity2"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-1-ImpurityUnspecified"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-1-ImpurityTotal"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-1-Identification"/>
</hasMember>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:3b550915-4467-83d3-340f-9bd6d2857191"/>
<resource>
<Specimen>
<!-- stabilityInitial-2 -->
<id value="3b550915-4467-83d3-340f-9bd6d2857191"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="3b550915-4467-83d3-340f-9bd6d2857191"> </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 Specimen "3b550915-4467-83d3-340f-9bd6d2857191" </p></div><h3>Collections</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Collected[x]</b></td></tr><tr><td style="display: none">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>
</text>
<!-- when sample first taken, before the timed periods start -->
<collection>
<collectedDateTime value="2020-06"/>
</collection>
<processing>
<description value="No storage"/>
</processing>
<processing>
<description value="25°C/60% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Long Term XYZ - Initial - on batch 2 -->
<entry>
<fullUrl value="urn:uuid:930c7f69-2546-7148-2069-b3be3a755edf"/>
<resource>
<Observation>
<!-- LongTerm30C-Initial-2 -->
<id value="930c7f69-2546-7148-2069-b3be3a755edf"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="930c7f69-2546-7148-2069-b3be3a755edf"> </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 Observation "930c7f69-2546-7148-2069-b3be3a755edf" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_10d7b693-7a0e-2f71-9a10-642e5a0a5d42">See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href="#Specimen_3b550915-4467-83d3-340f-9bd6d2857191">See above (Specimen/3b550915-4467-83d3-340f-9bd6d2857191)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm30C-initial-2-Description"> </a></li><li><a name="LongTerm30C-initial-2-Assay"> </a></li><li><a name="LongTerm30C-initial-2-Degradation-imp1"> </a></li><li><a name="LongTerm30C-initial-2-Degradation-imp2"> </a></li><li><a name="LongTerm30C-initial-2-Degradation-impUnspecified"> </a></li><li><a name="LongTerm30C-initial-2-Degradation-impTotal"> </a></li><li><a name="LongTerm30C-initial-2-Identification"> </a></li></ul><blockquote><p/><p><a name="LongTerm30C-initial-2-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-2-Assay"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.152 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-2-Degradation-imp1"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.12 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-2-Degradation-imp2"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.22 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-2-Degradation-impUnspecified"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.052 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-2-Degradation-impTotal"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.82 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-2-Identification"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Does not comply <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Description</b><a name="LongTerm30C-initial-2-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-imp1</b><a name="LongTerm30C-initial-2-Degradation-imp1"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.12 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-imp2</b><a name="LongTerm30C-initial-2-Degradation-imp2"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.22 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-impUnspecified</b><a name="LongTerm30C-initial-2-Degradation-impUnspecified"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.052 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-impTotal</b><a name="LongTerm30C-initial-2-Degradation-impTotal"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.82 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Assay</b><a name="LongTerm30C-initial-2-Assay"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.152 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-2-Identification</b><a name="LongTerm30C-initial-2-Identification"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Does not comply <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm30C-initial-2-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-2-Degradation-imp1"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.12"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-2-Degradation-imp2"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.22"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-2-Degradation-impUnspecified"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.052"/>
<comparator value="<"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-2-Degradation-impTotal"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.82"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-2-Assay"/>
<instantiatesReference>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.152"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-2-Identification"/>
<instantiatesReference>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Does not comply"/>
</valueCodeableConcept>
</Observation>
</contained>
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityLongTerm30XY-Initial -->
<reference
value="ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Long-term 25C etc - Initial (XYZ)"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<specimen>
<!-- Specimen/stabilityInitial-2 -->
<reference value="Specimen/3b550915-4467-83d3-340f-9bd6d2857191"/>
</specimen>
<hasMember>
<reference value="#LongTerm30C-initial-2-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-2-Assay"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-2-Degradation-imp1"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-2-Degradation-imp2"/>
</hasMember>
<hasMember>
<reference
value="#LongTerm30C-initial-2-Degradation-impUnspecified"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-2-Degradation-impTotal"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-2-Identification"/>
</hasMember>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:b1726ce3-8bb5-403e-2e9b-f5d79cc716f9"/>
<resource>
<Specimen>
<!-- stabilityInitial-3 -->
<id value="b1726ce3-8bb5-403e-2e9b-f5d79cc716f9"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="b1726ce3-8bb5-403e-2e9b-f5d79cc716f9"> </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 Specimen "b1726ce3-8bb5-403e-2e9b-f5d79cc716f9" </p></div><h3>Collections</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Collected[x]</b></td></tr><tr><td style="display: none">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>
</text>
<!-- when sample first taken, before the timed periods start -->
<collection>
<collectedDateTime value="2020-06"/>
</collection>
<processing>
<description value="No storage"/>
</processing>
<processing>
<description value="25°C/60% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Long Term XYZ - Initial - on batch 3 -->
<entry>
<fullUrl value="urn:uuid:8070745c-30c4-a52e-41fd-600a913578d4"/>
<resource>
<Observation>
<!-- LongTerm30C-Initial-3 -->
<id value="8070745c-30c4-a52e-41fd-600a913578d4"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="8070745c-30c4-a52e-41fd-600a913578d4"> </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 Observation "8070745c-30c4-a52e-41fd-600a913578d4" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_10d7b693-7a0e-2f71-9a10-642e5a0a5d42">See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href="#Specimen_b1726ce3-8bb5-403e-2e9b-f5d79cc716f9">See above (Specimen/b1726ce3-8bb5-403e-2e9b-f5d79cc716f9)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm30C-initial-3-Description"> </a></li><li><a name="LongTerm30C-initial-3-Assay"> </a></li><li><a name="LongTerm30C-initial-3-Degradation-imp1"> </a></li><li><a name="LongTerm30C-initial-3-Degradation-imp2"> </a></li><li><a name="LongTerm30C-initial-3-Degradation-impUnspecified"> </a></li><li><a name="LongTerm30C-initial-3-Degradation-impTotal"> </a></li><li><a name="LongTerm30C-initial-3-Identification"> </a></li></ul><blockquote><p/><p><a name="LongTerm30C-initial-3-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-3-Assay"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.152 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-3-Degradation-imp1"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.12 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-3-Degradation-imp2"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.22 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-3-Degradation-impUnspecified"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.052 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-3-Degradation-impTotal"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.82 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-initial-3-Identification"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Does not comply <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Description</b><a name="LongTerm30C-initial-3-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-imp1</b><a name="LongTerm30C-initial-3-Degradation-imp1"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.12 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-imp2</b><a name="LongTerm30C-initial-3-Degradation-imp2"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.22 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-impUnspecified</b><a name="LongTerm30C-initial-3-Degradation-impUnspecified"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.052 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-impTotal</b><a name="LongTerm30C-initial-3-Degradation-impTotal"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.82 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Assay</b><a name="LongTerm30C-initial-3-Assay"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.152 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-initial-3-Identification</b><a name="LongTerm30C-initial-3-Identification"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Does not comply <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm30C-initial-3-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-3-Degradation-imp1"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.12"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-3-Degradation-imp2"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.22"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-3-Degradation-impUnspecified"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.052"/>
<comparator value="<"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-3-Degradation-impTotal"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.82"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-3-Assay"/>
<instantiatesReference>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.152"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-initial-3-Identification"/>
<instantiatesReference>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Does not comply"/>
</valueCodeableConcept>
</Observation>
</contained>
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityLongTerm30XY-Initial -->
<reference
value="ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Long-term 25C etc - Initial (XYZ)"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<specimen>
<!-- Specimen/stabilityInitial-3 -->
<reference value="Specimen/b1726ce3-8bb5-403e-2e9b-f5d79cc716f9"/>
</specimen>
<hasMember>
<reference value="#LongTerm30C-initial-3-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-3-Assay"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-3-Degradation-imp1"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-3-Degradation-imp2"/>
</hasMember>
<hasMember>
<reference
value="#LongTerm30C-initial-3-Degradation-impUnspecified"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-3-Degradation-impTotal"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-initial-3-Identification"/>
</hasMember>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:7aa5fdea-17d7-29f1-1ed4-5c05eb62285a"/>
<resource>
<Specimen>
<!-- stability18months-1 -->
<id value="7aa5fdea-17d7-29f1-1ed4-5c05eb62285a"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="7aa5fdea-17d7-29f1-1ed4-5c05eb62285a"> </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 Specimen "7aa5fdea-17d7-29f1-1ed4-5c05eb62285a" </p></div><h3>Collections</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Collected[x]</b></td></tr><tr><td style="display: none">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 30°C/65% RH</p></blockquote></div>
</text>
<collection>
<collectedDateTime value="2020-06"/>
</collection>
<processing>
<description value="Store for 18 months"/>
<timePeriod>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq">
<valueDuration>
<value value="18"/>
<unit value="month"/>
</valueDuration>
</extension>
<start value="2020-12"/>
<end value="2022-06"/>
</timePeriod>
</processing>
<processing>
<description value="30°C/65% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:872a645f-120e-44c0-62c0-9be05acf543b"/>
<resource>
<Specimen>
<!-- stability18months-2 -->
<id value="872a645f-120e-44c0-62c0-9be05acf543b"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="872a645f-120e-44c0-62c0-9be05acf543b"> </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 Specimen "872a645f-120e-44c0-62c0-9be05acf543b" </p></div><h3>Collections</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Collected[x]</b></td></tr><tr><td style="display: none">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 30°C/65% RH</p></blockquote></div>
</text>
<collection>
<collectedDateTime value="2020-06"/>
</collection>
<processing>
<description value="Store for 18 months"/>
<timePeriod>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq">
<valueDuration>
<value value="18"/>
<unit value="month"/>
</valueDuration>
</extension>
<start value="2020-12"/>
<end value="2022-06"/>
</timePeriod>
</processing>
<processing>
<description value="30°C/65% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:7c06a03c-9cf7-2e1b-a236-d60038f1439b"/>
<resource>
<Specimen>
<!-- stability18months-3 -->
<id value="7c06a03c-9cf7-2e1b-a236-d60038f1439b"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="7c06a03c-9cf7-2e1b-a236-d60038f1439b"> </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 Specimen "7c06a03c-9cf7-2e1b-a236-d60038f1439b" </p></div><h3>Collections</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Collected[x]</b></td></tr><tr><td style="display: none">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 30°C/65% RH</p></blockquote></div>
</text>
<collection>
<collectedDateTime value="2020-06"/>
</collection>
<processing>
<description value="Store for 18 months"/>
<timePeriod>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq">
<valueDuration>
<value value="18"/>
<unit value="month"/>
</valueDuration>
</extension>
<start value="2020-12"/>
<end value="2022-06"/>
</timePeriod>
</processing>
<processing>
<description value="30°C/65% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:f16113fe-27e7-0aa2-6787-9415f5051900"/>
<resource>
<Observation>
<!-- LongTerm30C-18m -->
<id value="f16113fe-27e7-0aa2-6787-9415f5051900"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="f16113fe-27e7-0aa2-6787-9415f5051900"> </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 Observation "f16113fe-27e7-0aa2-6787-9415f5051900" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_c9b53a46-2f61-7b3f-5780-5f5c79a47f12">See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)</a></p><p><b>status</b>: final</p><p><b>code</b>: Long-term - 30°C/65% RH - 18 months (X) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href="#Specimen_7aa5fdea-17d7-29f1-1ed4-5c05eb62285a">See above (Specimen/7aa5fdea-17d7-29f1-1ed4-5c05eb62285a)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm30C-18m-1-Description"> </a></li><li><a name="LongTerm30C-18m-1-Assay"> </a></li><li><a name="LongTerm30C-18m-1-Impurity1"> </a></li><li><a name="LongTerm30C-18m-1-Impurity2"> </a></li><li><a name="LongTerm30C-18m-1-ImpurityUnspecified"> </a></li><li><a name="LongTerm30C-18m-1-ImpurityTotal"> </a></li><li><a name="LongTerm30C-18m-1-Identification"> </a></li></ul><blockquote><p/><p><a name="LongTerm30C-18m-1-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-1-Assay"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-1-Impurity1"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-1-Impurity2"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.218 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-1-ImpurityUnspecified"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.0518 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-1-ImpurityTotal"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.818 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-1-Identification"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-Description</b><a name="LongTerm30C-18m-1-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-Impurity1</b><a name="LongTerm30C-18m-1-Impurity1"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-Impurity2</b><a name="LongTerm30C-18m-1-Impurity2"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.218 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-ImpurityUnspecified</b><a name="LongTerm30C-18m-1-ImpurityUnspecified"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.0518 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-ImpurityTotal</b><a name="LongTerm30C-18m-1-ImpurityTotal"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.818 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-Assay</b><a name="LongTerm30C-18m-1-Assay"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-1-Identification</b><a name="LongTerm30C-18m-1-Identification"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm30C-18m-1-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-1-Impurity1"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.118"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-1-Impurity2"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.218"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-1-ImpurityUnspecified"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.0518"/>
<comparator value="<"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-1-ImpurityTotal"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.818"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-1-Assay"/>
<instantiatesReference>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.118"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-1-Identification"/>
<instantiatesReference>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<!-- use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityLongTerm30X-18 -->
<reference
value="ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Long-term - 30°C/65% RH - 18 months (X)"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<specimen>
<!-- Specimen/stability18months-1 -->
<reference value="Specimen/7aa5fdea-17d7-29f1-1ed4-5c05eb62285a"/>
</specimen>
<hasMember>
<reference value="#LongTerm30C-18m-1-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-1-Assay"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-1-Impurity1"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-1-Impurity2"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-1-ImpurityUnspecified"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-1-ImpurityTotal"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-1-Identification"/>
</hasMember>
</Observation>
</resource>
</entry>
<!-- batch 2 -->
<entry>
<fullUrl value="urn:uuid:1b25eb25-9149-02f6-9676-c87f90c64904"/>
<resource>
<Observation>
<!-- LongTerm30C-18m-2 -->
<id value="1b25eb25-9149-02f6-9676-c87f90c64904"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="1b25eb25-9149-02f6-9676-c87f90c64904"> </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 Observation "1b25eb25-9149-02f6-9676-c87f90c64904" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_c9b53a46-2f61-7b3f-5780-5f5c79a47f12">See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)</a></p><p><b>status</b>: final</p><p><b>code</b>: Long-term - 30°C/65% RH - 18 months (X) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href="#Specimen_872a645f-120e-44c0-62c0-9be05acf543b">See above (Specimen/872a645f-120e-44c0-62c0-9be05acf543b)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm30C-18m-2-Description"> </a></li><li><a name="LongTerm30C-18m-2-Assay"> </a></li><li><a name="LongTerm30C-18m-2-Impurity1"> </a></li><li><a name="LongTerm30C-18m-2-Impurity2"> </a></li><li><a name="LongTerm30C-18m-2-ImpurityUnspecified"> </a></li><li><a name="LongTerm30C-18m-2-ImpurityTotal"> </a></li><li><a name="LongTerm30C-18m-2-Identification"> </a></li></ul><blockquote><p/><p><a name="LongTerm30C-18m-2-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-2-Assay"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-2-Impurity1"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-2-Impurity2"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.218 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-2-ImpurityUnspecified"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.0518 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-2-ImpurityTotal"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.818 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-2-Identification"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="#Substance_cbcecab6-374c-396f-29be-877da7285e8d">See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-Description</b><a name="LongTerm30C-18m-2-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-Impurity1</b><a name="LongTerm30C-18m-2-Impurity1"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-Impurity2</b><a name="LongTerm30C-18m-2-Impurity2"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.218 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-ImpurityUnspecified</b><a name="LongTerm30C-18m-2-ImpurityUnspecified"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.0518 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-ImpurityTotal</b><a name="LongTerm30C-18m-2-ImpurityTotal"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.818 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-Assay</b><a name="LongTerm30C-18m-2-Assay"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-2-Identification</b><a name="LongTerm30C-18m-2-Identification"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_cbcecab6-374c-396f-29be-877da7285e8d">Substance/cbcecab6-374c-396f-29be-877da7285e8d</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm30C-18m-2-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-2-Impurity1"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.118"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-2-Impurity2"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.218"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-2-ImpurityUnspecified"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.0518"/>
<comparator value="<"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-2-ImpurityTotal"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.818"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-2-Assay"/>
<instantiatesReference>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.118"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-2-Identification"/>
<instantiatesReference>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<!-- use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityLongTerm30X-18 -->
<reference
value="ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Long-term - 30°C/65% RH - 18 months (X)"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-2 -->
<reference value="Substance/cbcecab6-374c-396f-29be-877da7285e8d"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<specimen>
<!-- Specimen/stability18months-2 -->
<reference value="Specimen/872a645f-120e-44c0-62c0-9be05acf543b"/>
</specimen>
<hasMember>
<reference value="#LongTerm30C-18m-2-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-2-Assay"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-2-Impurity1"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-2-Impurity2"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-2-ImpurityUnspecified"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-2-ImpurityTotal"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-2-Identification"/>
</hasMember>
</Observation>
</resource>
</entry>
<!-- batch 3 -->
<entry>
<fullUrl value="urn:uuid:004ed877-7729-834e-3b6b-a2cf4bdb2377"/>
<resource>
<Observation>
<!-- LongTerm30C-18m-3 -->
<id value="004ed877-7729-834e-3b6b-a2cf4bdb2377"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="004ed877-7729-834e-3b6b-a2cf4bdb2377"> </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 Observation "004ed877-7729-834e-3b6b-a2cf4bdb2377" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_c9b53a46-2f61-7b3f-5780-5f5c79a47f12">See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)</a></p><p><b>status</b>: final</p><p><b>code</b>: Long-term - 30°C/65% RH - 18 months (X) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href="#Specimen_7c06a03c-9cf7-2e1b-a236-d60038f1439b">See above (Specimen/7c06a03c-9cf7-2e1b-a236-d60038f1439b)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm30C-18m-3-Description"> </a></li><li><a name="LongTerm30C-18m-3-Assay"> </a></li><li><a name="LongTerm30C-18m-3-Impurity1"> </a></li><li><a name="LongTerm30C-18m-3-Impurity2"> </a></li><li><a name="LongTerm30C-18m-3-ImpurityUnspecified"> </a></li><li><a name="LongTerm30C-18m-3-ImpurityTotal"> </a></li><li><a name="LongTerm30C-18m-3-Identification"> </a></li></ul><blockquote><p/><p><a name="LongTerm30C-18m-3-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-3-Assay"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-3-Impurity1"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-3-Impurity2"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.218 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-3-ImpurityUnspecified"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.0518 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-3-ImpurityTotal"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.818 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm30C-18m-3-Identification"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-Description</b><a name="LongTerm30C-18m-3-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-Impurity1</b><a name="LongTerm30C-18m-3-Impurity1"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-Impurity2</b><a name="LongTerm30C-18m-3-Impurity2"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.218 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-ImpurityUnspecified</b><a name="LongTerm30C-18m-3-ImpurityUnspecified"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.0518 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-ImpurityTotal</b><a name="LongTerm30C-18m-3-ImpurityTotal"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.818 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-Assay</b><a name="LongTerm30C-18m-3-Assay"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.118 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm30C-18m-3-Identification</b><a name="LongTerm30C-18m-3-Identification"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm30C-18m-3-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-3-Impurity1"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.118"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-3-Impurity2"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.218"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-3-ImpurityUnspecified"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.0518"/>
<comparator value="<"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-3-ImpurityTotal"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.818"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-3-Assay"/>
<instantiatesReference>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.118"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm30C-18m-3-Identification"/>
<instantiatesReference>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<!-- use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityLongTerm30X-18 -->
<reference
value="ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Long-term - 30°C/65% RH - 18 months (X)"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<specimen>
<!-- Specimen/stability18months-3 -->
<reference value="Specimen/7c06a03c-9cf7-2e1b-a236-d60038f1439b"/>
</specimen>
<hasMember>
<reference value="#LongTerm30C-18m-3-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-3-Assay"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-3-Impurity1"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-3-Impurity2"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-3-ImpurityUnspecified"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-3-ImpurityTotal"/>
</hasMember>
<hasMember>
<reference value="#LongTerm30C-18m-3-Identification"/>
</hasMember>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:b04c9321-069c-4da8-8ed0-86337ea22c30"/>
<resource>
<Specimen>
<!-- acceleratedInitial-3m-1 -->
<id value="b04c9321-069c-4da8-8ed0-86337ea22c30"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="b04c9321-069c-4da8-8ed0-86337ea22c30"> </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 Specimen "b04c9321-069c-4da8-8ed0-86337ea22c30" </p></div><h3>Collections</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Collected[x]</b></td></tr><tr><td style="display: none">*</td><td>2020-06</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 40°C/75% RH</p></blockquote></div>
</text>
<collection>
<collectedDateTime value="2020-06"/>
</collection>
<processing>
<description value="No storage"/>
</processing>
<processing>
<description value="40°C/75% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:f958e1e9-6023-4e39-2ffe-a9c8f135a2dd"/>
<resource>
<Observation>
<!-- Accelerated40C-3m -->
<id value="f958e1e9-6023-4e39-2ffe-a9c8f135a2dd"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="f958e1e9-6023-4e39-2ffe-a9c8f135a2dd"> </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 Observation "f958e1e9-6023-4e39-2ffe-a9c8f135a2dd" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9">See above (ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9)</a></p><p><b>status</b>: final</p><p><b>code</b>: Accelerated - 40°C/67% RH - 3 months (X) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>specimen</b>: <a href="#Specimen_b04c9321-069c-4da8-8ed0-86337ea22c30">See above (Specimen/b04c9321-069c-4da8-8ed0-86337ea22c30)</a></p><p><b>hasMember</b>: </p><ul><li><a name="Accelerated40C-3m-1-Description"> </a></li><li><a name="Accelerated40C-3m-1-Assay"> </a></li><li><a name="Accelerated40C-3m-1-Impurity1"> </a></li><li><a name="Accelerated40C-3m-1-Impurity2"> </a></li><li><a name="Accelerated40C-3m-1-ImpurityUnspecified"> </a></li><li><a name="Accelerated40C-3m-1-ImpurityTotal"> </a></li><li><a name="Accelerated40C-3m-1-Identification"> </a></li></ul><blockquote><p/><p><a name="Accelerated40C-3m-1-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Doesn't comply <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="Accelerated40C-3m-1-Assay"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.113 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="Accelerated40C-3m-1-Impurity1"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.113 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="Accelerated40C-3m-1-Impurity2"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.213 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="Accelerated40C-3m-1-ImpurityUnspecified"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: <0.0513 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="Accelerated40C-3m-1-ImpurityTotal"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.813 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="Accelerated40C-3m-1-Identification"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-Description</b><a name="Accelerated40C-3m-1-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_559ffdc3-349b-a4a3-a651-ce2715f08d69">ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Doesn't comply <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-Impurity1</b><a name="Accelerated40C-3m-1-Impurity1"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.113 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-Impurity2</b><a name="Accelerated40C-3m-1-Impurity2"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.213 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-ImpurityUnspecified</b><a name="Accelerated40C-3m-1-ImpurityUnspecified"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_a3fdc23b-6c16-2e65-481e-3fc895b37b87">Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: <0.0513 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-ImpurityTotal</b><a name="Accelerated40C-3m-1-ImpurityTotal"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.813 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-Assay</b><a name="Accelerated40C-3m-1-Assay"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_7943795a-2abe-666f-545f-133e23b97119">ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: 0.113 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3m-1-Identification</b><a name="Accelerated40C-3m-1-Identification"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#ObservationDefinition_6b96124b-1a44-0b6b-6783-d6c49360230b">ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex2-sub.html#Substance_ae1f3b4c-4f14-1460-6903-7260959ea2cd">Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1.html#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">Organization/378fbe5f-5926-3a5c-4c64-5428df877b08</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="Accelerated40C-3m-1-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Doesn't comply"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3m-1-Impurity1"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.113"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3m-1-Impurity2"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.213"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3m-1-ImpurityUnspecified"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference
value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.0513"/>
<comparator value="<"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3m-1-ImpurityTotal"/>
<instantiatesReference>
<!-- ObservationDefinition/Impurities -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Impurities"/>
<display value="Impurities"/>
</coding>
<text value="Impurities"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.813"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3m-1-Assay"/>
<instantiatesReference>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.113"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3m-1-Identification"/>
<instantiatesReference>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<subject>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<!-- use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityAccelerated40X-3 -->
<reference
value="ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Accelerated - 40°C/67% RH - 3 months (X)"/>
</code>
<subject>
<!-- Substance/actual-batch-substance -->
<reference value="Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<specimen>
<!-- Specimen/acceleratedInitial-3m-1 -->
<reference value="Specimen/b04c9321-069c-4da8-8ed0-86337ea22c30"/>
</specimen>
<hasMember>
<reference value="#Accelerated40C-3m-1-Description"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3m-1-Assay"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3m-1-Impurity1"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3m-1-Impurity2"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3m-1-ImpurityUnspecified"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3m-1-ImpurityTotal"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3m-1-Identification"/>
</hasMember>
</Observation>
</resource>
</entry>
<!-- Section 4.1 - Manufacturer -->
<entry>
<fullUrl value="urn:uuid:62c1b1b4-8d15-26d2-57f9-25a2f60b6181"/>
<resource>
<Organization>
<!-- manufacturer -->
<id value="62c1b1b4-8d15-26d2-57f9-25a2f60b6181"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="62c1b1b4-8d15-26d2-57f9-25a2f60b6181"> </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 "62c1b1b4-8d15-26d2-57f9-25a2f60b6181" </p></div><p><b>identifier</b>: id: 3003040516</p><p><b>name</b>: AAA Molybdenum Products, Inc.</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>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>
</text>
<identifier>
<!-- FDA establishment identifier -->
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3003040516"/>
</identifier>
<name value="AAA Molybdenum Products, Inc."/>
<contact>
<address>
<line value="7233 W 116th Pl"/>
<line value="Ste C"/>
<city value="Broomfield"/>
<state value="Colorado"/>
<postalCode value="80020"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<!-- Section 4.2 - Testing Site -->
<entry>
<fullUrl value="urn:uuid:6049d921-9935-90b7-4efc-894a66483c00"/>
<resource>
<Organization>
<!-- tester -->
<id value="6049d921-9935-90b7-4efc-894a66483c00"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="6049d921-9935-90b7-4efc-894a66483c00"> </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 "6049d921-9935-90b7-4efc-894a66483c00" </p></div><p><b>identifier</b>: id: 3007270600</p><p><b>name</b>: Advanced Analytical Testing Laboratories Inc.</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>30 Silverline Drive North Brunswick New Jersey 08902 USA </td></tr></table></div>
</text>
<!-- could also use assigner here, for #74 -->
<identifier>
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3007270600"/>
</identifier>
<name value="Advanced Analytical Testing Laboratories Inc."/>
<contact>
<address>
<line value="30 Silverline Drive"/>
<city value="North Brunswick"/>
<state value="New Jersey"/>
<postalCode value="08902"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:2e3a85b5-790a-a108-3627-edf0ec6f1210"/>
<resource>
<SubstanceDefinition>
<!-- substance1 -->
<id value="2e3a85b5-790a-a108-3627-edf0ec6f1210"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="2e3a85b5-790a-a108-3627-edf0ec6f1210"> </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 "2e3a85b5-790a-a108-3627-edf0ec6f1210" </p></div><p><b>identifier</b>: id: 4444455555</p><p><b>manufacturer</b>: <a href="#Organization_62c1b1b4-8d15-26d2-57f9-25a2f60b6181">See above (Organization/62c1b1b4-8d15-26d2-57f9-25a2f60b6181)</a></p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol</td></tr></table></div>
</text>
<identifier>
<system
value="http://example.company.org/companySubstanceIdentifier"/>
<value value="4444455555"/>
</identifier>
<manufacturer>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq">
<valueCoding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productSiteUtilizationType-local-pq"/>
<code value="Release stability"/>
<display value="Release stability"/>
</valueCoding>
</extension>
<!-- Organization/manufacturer -->
<reference
value="Organization/62c1b1b4-8d15-26d2-57f9-25a2f60b6181"/>
</manufacturer>
<name>
<name value="Stelbatolol"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:e2359a4e-3091-23f8-2242-87e701830d55"/>
<resource>
<Organization>
<!-- substance-manufacturer -->
<id value="e2359a4e-3091-23f8-2242-87e701830d55"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="e2359a4e-3091-23f8-2242-87e701830d55"> </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 "e2359a4e-3091-23f8-2242-87e701830d55" </p></div><p><b>identifier</b>: id: 3003040516</p><p><b>name</b>: AAA Molybdenum Products, Inc.</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>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>
</text>
<identifier>
<!-- FDA establishment identifier -->
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3003040516"/>
</identifier>
<name value="AAA Molybdenum Products, Inc."/>
<contact>
<address>
<line value="7233 W 116th Pl"/>
<line value="Ste C"/>
<city value="Broomfield"/>
<state value="Colorado"/>
<postalCode value="80020"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08"/>
<resource>
<Organization>
<!-- testing lab -->
<!-- 378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<id value="378fbe5f-5926-3a5c-4c64-5428df877b08"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="378fbe5f-5926-3a5c-4c64-5428df877b08"> </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 "378fbe5f-5926-3a5c-4c64-5428df877b08" </p></div><p><b>name</b>: Testing Lab</p></div>
</text>
<name value="Testing Lab"/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
<resource>
<Substance>
<!-- actual-batch-substance -->
<id value="a3fdc23b-6c16-2e65-481e-3fc895b37b87"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Substance</b><a name="a3fdc23b-6c16-2e65-481e-3fc895b37b87"> </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 Substance "a3fdc23b-6c16-2e65-481e-3fc895b37b87" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-01</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href="#Organization_e2359a4e-3091-23f8-2242-87e701830d55">See above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)</a></p><blockquote><p><b>url</b></p><code>container</code></blockquote></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id: CAT1</p><p><b>instance</b>: true</p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="#SubstanceDefinition_2e3a85b5-790a-a108-3627-edf0ec6f1210">See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="manufacturingDate">
<valueDateTime value="2020-01"/>
</extension>
<extension url="batchQuantity">
<valueQuantity>
<value value="120"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<!-- could also be C185328 Stability Study? -->
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C133990"/>
<display value="Commercial"/>
</coding>
<text value="Production"/>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>
<!-- Organization/substance-manufacturer -->
<reference
value="Organization/e2359a4e-3091-23f8-2242-87e701830d55"/>
</valueReference>
</extension>
<extension url="container">
<extension url="type">
<valueCodeableConcept>
<text value="packaged in LDPE bags within HDPE drums"/>
</valueCodeableConcept>
</extension>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq">
<valueDateTime value="2019-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq">
<valueDateTime value="2022-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.8"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<identifier>
<value value="CAT1"/>
</identifier>
<instance value="true"/>
<code>
<reference>
<!-- SubstanceDefinition/substance1 -->
<reference
value="SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210"/>
</reference>
</code>
</Substance>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:cbcecab6-374c-396f-29be-877da7285e8d"/>
<resource>
<Substance>
<!-- actual-batch-substance-2 -->
<id value="cbcecab6-374c-396f-29be-877da7285e8d"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Substance</b><a name="cbcecab6-374c-396f-29be-877da7285e8d"> </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 Substance "cbcecab6-374c-396f-29be-877da7285e8d" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-02</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href="#Organization_e2359a4e-3091-23f8-2242-87e701830d55">See above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id: CAT2</p><p><b>instance</b>: true</p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="#SubstanceDefinition_2e3a85b5-790a-a108-3627-edf0ec6f1210">See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="manufacturingDate">
<valueDateTime value="2020-02"/>
</extension>
<extension url="batchQuantity">
<valueQuantity>
<value value="120"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<!-- could also be C185328 Stability Study? -->
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C133990"/>
<display value="Commercial"/>
</coding>
<text value="Production"/>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>
<!-- Organization/substance-manufacturer -->
<reference
value="Organization/e2359a4e-3091-23f8-2242-87e701830d55"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq">
<valueDateTime value="2019-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq">
<valueDateTime value="2022-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.8"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<identifier>
<value value="CAT2"/>
</identifier>
<instance value="true"/>
<code>
<reference>
<!-- SubstanceDefinition/substance1 -->
<reference
value="SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210"/>
</reference>
</code>
</Substance>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
<resource>
<Substance>
<!-- actual-batch-substance-3 -->
<id value="ae1f3b4c-4f14-1460-6903-7260959ea2cd"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Substance</b><a name="ae1f3b4c-4f14-1460-6903-7260959ea2cd"> </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 Substance "ae1f3b4c-4f14-1460-6903-7260959ea2cd" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-03</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href="#Organization_e2359a4e-3091-23f8-2242-87e701830d55">See above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id: CAT3</p><p><b>instance</b>: true</p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="#SubstanceDefinition_2e3a85b5-790a-a108-3627-edf0ec6f1210">See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="manufacturingDate">
<valueDateTime value="2020-03"/>
</extension>
<extension url="batchQuantity">
<valueQuantity>
<value value="120"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<!-- could also be C185328 Stability Study? -->
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C133990"/>
<display value="Commercial"/>
</coding>
<text value="Production"/>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>
<!-- Organization/substance-manufacturer -->
<reference
value="Organization/e2359a4e-3091-23f8-2242-87e701830d55"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq">
<valueDateTime value="2019-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq">
<valueDateTime value="2022-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.8"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<identifier>
<value value="CAT3"/>
</identifier>
<instance value="true"/>
<code>
<reference>
<!-- SubstanceDefinition/substance1 -->
<reference
value="SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210"/>
</reference>
</code>
</Substance>
</resource>
</entry>
</Bundle>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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