Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc/ and changes regularly. See the Directory of published versions
| Active as of 2022-12-08 |
<PlanDefinition xmlns="http://hl7.org/fhir">
<id value="aa514363-d43f-4052-b44e-b67aa4d6dee7"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="aa514363-d43f-4052-b44e-b67aa4d6dee7"> </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 "aa514363-d43f-4052-b44e-b67aa4d6dee7" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-quality-specification.html">Quality Specification</a></p></div><p><b>Specification Type</b>: Drug Product <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134021)</span></p><p><b>StructureDefinition Work Group</b>: brr</p><p><b>url</b>: <code>http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7</code></p><p><b>identifier</b>: ExampleSpecification</p><p><b>version</b>: 0.1.20</p><p><b>title</b>: Quality Specification for Buffered Asprin</p><p><b>status</b>: active</p><p><b>subject</b>: <a href="Bundle-4a7e17c1-a611-4cc7-9a71-8005a8b427ab.html#urn-uuid-89676a69-1fe7-422c-ab00-92abe4ef6ea9">urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9</a></p><p><b>date</b>: 2022-12-08</p><p><b>publisher</b>: HL7 International / Biomedical Research and Regulation</p><p><b>contact</b>: HL7 International / Biomedical Research and Regulation: <a href="http://www.hl7.org/Special/committees/rcrim">http://www.hl7.org/Special/committees/rcrim</a>,<a href="mailto:brr@lists.HL7.org">brr@lists.HL7.org</a></p><h3>UseContexts</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>Workflow Setting (Details: http://terminology.hl7.org/CodeSystem/usage-context-type code workflow = 'Workflow Setting', stated as 'Workflow Setting')</td><td>Not Approved <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134011)</span></td></tr></table><p><b>jurisdiction</b>: United States of America <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#US)</span></p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>32649771-1290-4386-9cf7-7a72274f22b4</blockquote><p><b>description</b>: Average of 10 between 2-3 pH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>2-3 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>59a4ca76-858e-4d58-8e5f-88e75f51ec33</blockquote><p><b>description</b>: Maxima only at the same wavelengths compared to reference standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Conforms <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>c40aa176-e6aa-4fe4-869d-6550ee992903</blockquote><p><b>description</b>: <= 0.5 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.5 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>b122987d-586c-481b-951c-6202e660158d</blockquote><p><b>description</b>: Color of solution is clear <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Conforms <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>929747ad-e83a-46f0-bbbc-133ee951e819</blockquote><p><b>description</b>: <= 0.05 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.05 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>8d7c85c2-7a4b-432e-ac94-226f296e4fca</blockquote><p><b>description</b>: No Particulate Matter detected <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>pass <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>de4f962a-d486-486d-8d84-f2d1635646b4</blockquote><p><b>description</b>: <= 0.014 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.014 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>b46dce64-a009-46cd-ab95-21d1d5b4df77</blockquote><p><b>description</b>: <= 0.04 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.04 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>5566f501-37e1-49fb-8783-b20c074ec0c3</blockquote><p><b>description</b>: <= 0.001 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.001 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>db19e3ab-e28b-4477-8bd7-2409093ed5a3</blockquote><p><b>description</b>: Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>pass <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>82370588-7aae-4556-9262-a7f50dbd01aa</blockquote><p><b>description</b>: Ethanol < 0.2% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Ethanol <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>0.2 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2</blockquote><p><b>description</b>: Ethyl Ether < 0.1% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Ethyl Ether <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>0.1 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>28ad4d5b-d975-4f6e-9792-b3d9cc7ce279</blockquote><p><b>description</b>: 1—propanol < 0.15% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>1—propanol <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>0.15 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>33fa051c-6b3c-4e4d-bd4e-09d39fc253b3</blockquote><p><b>description</b>: Total < 0.5% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Total Residual Solvents <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>0.5 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>9100e938-42ff-4004-8473-ed5090d66f3a</blockquote><p><b>description</b>: 99.5 - 100.5 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>99.5-100.5 percent</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>af260128-f105-4692-ba40-49f21f12ad46</blockquote><p><b>description</b>: n=6 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>6</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>31d9dcac-bf72-420b-a415-c924155a83f4</blockquote><p><b>description</b>: Each unit is NLT Q + 5% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>85 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>47c0d685-0b23-4637-9af8-a554e4fad7ec</blockquote><p><b>description</b>: n=6 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>6</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>14d3dee8-e024-4367-b0a2-a2a809303ee0</blockquote><p><b>description</b>: Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q – 15% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><blockquote><p><b>target</b></p><p><b>measure</b>: Average of 12 units <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>detail</b>: 80 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></p></blockquote><blockquote><p><b>target</b></p><p><b>measure</b>: unit <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>detail</b>: 65 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></p></blockquote></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>15309a78-92a9-4cf9-aee1-452d6d2f7a91</blockquote><p><b>description</b>: Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q – 15%, no unit is less than Q – 25% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><blockquote><p><b>target</b></p><p><b>measure</b>: Average of 24 units <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>detail</b>: 80 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></p></blockquote><blockquote><p><b>target</b></p><p><b>measure</b>: units less than Q – 15% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>detail</b>: 2 amb a 1 units<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C92953 = '[Amb'a'1'U]')</span></p></blockquote><blockquote><p><b>target</b></p><p><b>measure</b>: units less than Q – 25% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>detail</b>: 0 amb a 1 units<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C92953 = '[Amb'a'1'U]')</span></p></blockquote></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>666ace1e-bd29-4263-9ae2-2391106326bb</blockquote><p><b>description</b>: n=12 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>12</td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>2047a6b6-e3fc-4071-8989-526297579091</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1.1</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Spectrophotometry Identification</p><p><b>description</b>: Alternate</p><p><b>code</b>: Spectrophotometry <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC7)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <197></td></tr></table><p><b>goalId</b>: 32649771-1290-4386-9cf7-7a72274f22b4</p><h3>RelatedActions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>TargetId</b></td><td><b>Relationship</b></td></tr><tr><td style="display: none">*</td><td>84d64dd8-b799-418a-a713-a854c4d3c2b9</td><td>concurrent</td></tr></table><p><b>selectionBehavior</b>: exactly-one</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>84d64dd8-b799-418a-a713-a854c4d3c2b9</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1.2</p><p><b>linkId</b>: 2047a6b6-e3fc-4071-8989-526297579091</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Identity - Ferric Chloride</p><p><b>description</b>: Alternate</p><p><b>code</b>: HPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC7)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-01</td></tr></table><p><b>goalId</b>: 59a4ca76-858e-4d58-8e5f-88e75f51ec33</p><h3>RelatedActions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>TargetId</b></td><td><b>Relationship</b></td></tr><tr><td style="display: none">*</td><td>2047a6b6-e3fc-4071-8989-526297579091</td><td>concurrent</td></tr></table><p><b>selectionBehavior</b>: exactly-one</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>838e66ce-f4b0-47a5-8ea0-aa7882a84303</blockquote><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Loss on Drying</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Loss on Drying <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC12)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <731></td></tr></table><p><b>goalId</b>: c40aa176-e6aa-4fe4-869d-6550ee992903</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>3510686b-fb93-4980-a41c-0a3754be7f37</blockquote><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Readily Carbonizable Sub</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Organoleptic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC6)</span>, Color of solution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC22)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <271></td></tr></table><p><b>goalId</b>: b122987d-586c-481b-951c-6202e660158d</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>b2e18cc4-f494-4ef0-be34-810d8d4b439b</blockquote><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Residue on ignition (Ash)</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Residue on Ignition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC38)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <281></td></tr></table><p><b>goalId</b>: 929747ad-e83a-46f0-bbbc-133ee951e819</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>d315a1c3-dd93-498d-8ae3-dc0d4b3bec75</blockquote><p><b>Test Order | Stage Sequence Order</b>: 5</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Substances insoluble in sodium carbonate TS</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Foreign and Particulate Matter <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC11)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-02</td></tr></table><p><b>goalId</b>: 8d7c85c2-7a4b-432e-ac94-226f296e4fca</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>6ec15bbc-a78a-4351-9ad8-fcf97e839ab9</blockquote><p><b>Test Order | Stage Sequence Order</b>: 6</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Impurities - Chloride (Cl)</p><p><b>code</b>: FTIR <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, Specified identified impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC92)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <221></td></tr></table><p><b>goalId</b>: de4f962a-d486-486d-8d84-f2d1635646b4</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>fa31b425-896c-4b25-b693-ccdd14e0c8ee</blockquote><p><b>Test Order | Stage Sequence Order</b>: 7</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Impurities - Sulfate (SO4)</p><p><b>code</b>: FTIR <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, Specified identified impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC92)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <221></td></tr></table><p><b>goalId</b>: b46dce64-a009-46cd-ab95-21d1d5b4df77</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>cef5aa1a-8770-4f78-9bc3-da9f18b77e5c</blockquote><p><b>Test Order | Stage Sequence Order</b>: 8</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Elemental Impurities - Limits</p><p><b>code</b>: UV <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, elemental impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC98)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <231></td></tr></table><p><b>goalId</b>: 5566f501-37e1-49fb-8783-b20c074ec0c3</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>d5871ee2-8b06-414c-91b4-4b30f5881c8a</blockquote><p><b>Test Order | Stage Sequence Order</b>: 9</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Limit of Free Salicylic Acid</p><p><b>code</b>: Titration <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, Impurities/Degradation Products/Related Substances <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC100)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-03</td></tr></table><p><b>goalId</b>: db19e3ab-e28b-4477-8bd7-2409093ed5a3</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>e192fc72-c4b1-419f-8098-6f65037a3962</blockquote><p><b>Test Order | Stage Sequence Order</b>: 10</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Organic Volatile Impurities</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, residual solvent <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC101)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <467></td></tr></table><p><b>goalId</b>: 82370588-7aae-4556-9262-a7f50dbd01aa, cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2, 28ad4d5b-d975-4f6e-9792-b3d9cc7ce279, 33fa051c-6b3c-4e4d-bd4e-09d39fc253b3</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>b7e88ea0-3c61-49db-86ec-8d01f8b7667b</blockquote><p><b>Test Order | Stage Sequence Order</b>: 11</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Assay Dry Basis</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC1)</span>, active ingredient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC2)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-04</td></tr></table><p><b>goalId</b>: 9100e938-42ff-4004-8473-ed5090d66f3a</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>6d1ba5a8-6590-496a-ad6b-ca68cfda2878</blockquote><p><b>Test Order | Stage Sequence Order</b>: 12</p><p><b>title</b>: Dissolution - 30 minute</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Dissolution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC9)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-05</td></tr></table><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>LinkId</b></td><td><b>Prefix</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td/><td>6d1ba5a8-6590-496a-ad6b-ca68cfda2878</td><td>Stage 1</td><td>af260128-f105-4692-ba40-49f21f12ad46, 31d9dcac-bf72-420b-a415-c924155a83f4</td></tr><tr><td style="display: none">*</td><td/><td>6d1ba5a8-6590-496a-ad6b-ca68cfda2878</td><td>Stage 2</td><td>47c0d685-0b23-4637-9af8-a554e4fad7ec, 14d3dee8-e024-4367-b0a2-a2a809303ee0</td></tr><tr><td style="display: none">*</td><td/><td>6d1ba5a8-6590-496a-ad6b-ca68cfda2878</td><td>Stage 3</td><td>15309a78-92a9-4cf9-aee1-452d6d2f7a91, 666ace1e-bd29-4263-9ae2-2391106326bb</td></tr></table></blockquote></div>
</text>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134021"/>
<display value="Drug Product"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url
value="http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7"/>
<identifier>
<value value="ExampleSpecification"/>
</identifier>
<version value="0.1.20"/>
<title value="Quality Specification for Buffered Asprin"/>
<status value="active"/>
<subjectReference>
<reference value="urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9"/>
</subjectReference>
<date value="2022-12-08"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
<telecom>
<system value="email"/>
<value value="brr@lists.HL7.org"/>
</telecom>
</contact>
<useContext>
<code>
<system
value="http://terminology.hl7.org/CodeSystem/usage-context-type"/>
<code value="workflow"/>
<display value="Workflow Setting"/>
</code>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134011"/>
<display value="Not Approved"/>
</coding>
</valueCodeableConcept>
</useContext>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<goal id="32649771-1290-4386-9cf7-7a72274f22b4">
<description>
<text value="Average of 10 between 2-3 pH"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailRange>
<low>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
<display value="NLT (not less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="2"/>
<unit value="pH"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C45997"/>
</low>
<high>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61585"/>
<display value="LT (less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="3"/>
<unit value="pH"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C45997"/>
</high>
</detailRange>
</target>
</goal>
<goal id="59a4ca76-858e-4d58-8e5f-88e75f51ec33">
<description>
<text
value="Maxima only at the same wavelengths compared to reference standard"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="Conforms"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="c40aa176-e6aa-4fe4-869d-6550ee992903">
<description>
<text value="<= 0.5 %"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0.5"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="b122987d-586c-481b-951c-6202e660158d">
<description>
<text value="Color of solution is clear"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="Conforms"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="929747ad-e83a-46f0-bbbc-133ee951e819">
<description>
<text value="<= 0.05 %"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0.05"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="8d7c85c2-7a4b-432e-ac94-226f296e4fca">
<description>
<text value="No Particulate Matter detected"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="pass"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="de4f962a-d486-486d-8d84-f2d1635646b4">
<description>
<text value="<= 0.014 %"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0.014"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="b46dce64-a009-46cd-ab95-21d1d5b4df77">
<description>
<text value="<= 0.04 %"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0.04"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="5566f501-37e1-49fb-8783-b20c074ec0c3">
<description>
<text value="<= 0.001 %"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0.001"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="db19e3ab-e28b-4477-8bd7-2409093ed5a3">
<description>
<text
value="Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="pass"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="82370588-7aae-4556-9262-a7f50dbd01aa">
<description>
<text value="Ethanol < 0.2%"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<measure>
<text value="Ethanol"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61585"/>
<display value="LT (less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0.2"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2">
<description>
<text value="Ethyl Ether < 0.1%"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<measure>
<text value="Ethyl Ether"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61585"/>
<display value="LT (less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0.1"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="28ad4d5b-d975-4f6e-9792-b3d9cc7ce279">
<description>
<text value="1—propanol < 0.15%"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<measure>
<text value="1—propanol"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61585"/>
<display value="LT (less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0.15"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="33fa051c-6b3c-4e4d-bd4e-09d39fc253b3">
<description>
<text value="Total < 0.5%"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<measure>
<text value="Total Residual Solvents"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61585"/>
<display value="LT (less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0.5"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="9100e938-42ff-4004-8473-ed5090d66f3a">
<description>
<text value="99.5 - 100.5 %"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailRange>
<low>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
<display value="NLT (not less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="99.5"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</low>
<high>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="100.5"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</high>
</detailRange>
</target>
</goal>
<goal id="af260128-f105-4692-ba40-49f21f12ad46">
<description>
<text value="n=6"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailInteger value="6"/>
</target>
</goal>
<goal id="31d9dcac-bf72-420b-a415-c924155a83f4">
<description>
<text value="Each unit is NLT Q + 5%"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
<display value="NLT (not less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="85"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="47c0d685-0b23-4637-9af8-a554e4fad7ec">
<description>
<text value="n=6"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailInteger value="6"/>
</target>
</goal>
<goal id="14d3dee8-e024-4367-b0a2-a2a809303ee0">
<description>
<text
value="Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q – 15%"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<measure>
<text value="Average of 12 units"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
<display value="NLT (not less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="80"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
<target>
<measure>
<text value="unit"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61585"/>
<display value="LT (less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="65"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="15309a78-92a9-4cf9-aee1-452d6d2f7a91">
<description>
<text
value="Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q – 15%, no unit is less than Q – 25%"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<measure>
<text value="Average of 24 units"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
<display value="NLT (not less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="80"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
<target>
<measure>
<text value="units less than Q – 15%"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
<display value="NLT (not less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="2"/>
<unit value="amb a 1 units"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C92953"/>
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</target>
<target>
<measure>
<text value="units less than Q – 25%"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61585"/>
<display value="LT (less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0"/>
<unit value="amb a 1 units"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C92953"/>
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</target>
</goal>
<goal id="666ace1e-bd29-4263-9ae2-2391106326bb">
<description>
<text value="n=12"/>
</description>
<addresses>
<coding>
<system
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<code value="C134029"/>
<display value="Release"/>
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<target>
<detailInteger value="12"/>
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<action id="2047a6b6-e3fc-4071-8989-526297579091">
<extension
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<valueDecimal value="1.1"/>
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<prefix value="Single Stage"/>
<title value="Spectrophotometry Identification"/>
<description value="Alternate"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Spectrophotometry"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC7"/>
<display value="Identification"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <197>"/>
</documentation>
<goalId value="32649771-1290-4386-9cf7-7a72274f22b4"/>
<relatedAction>
<targetId value="84d64dd8-b799-418a-a713-a854c4d3c2b9"/>
<relationship value="concurrent"/>
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<selectionBehavior value="exactly-one"/>
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<action id="84d64dd8-b799-418a-a713-a854c4d3c2b9">
<extension
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<valueDecimal value="1.2"/>
</extension>
<linkId value="2047a6b6-e3fc-4071-8989-526297579091"/>
<prefix value="Single Stage"/>
<title value="Identity - Ferric Chloride"/>
<description value="Alternate"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="HPLC"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC7"/>
<display value="Identification"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-01"/>
</documentation>
<goalId value="59a4ca76-858e-4d58-8e5f-88e75f51ec33"/>
<relatedAction>
<targetId value="2047a6b6-e3fc-4071-8989-526297579091"/>
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<selectionBehavior value="exactly-one"/>
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<action id="838e66ce-f4b0-47a5-8ea0-aa7882a84303">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2"/>
</extension>
<prefix value="Single Stage"/>
<title value="Loss on Drying"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC12"/>
<display value="Loss on Drying"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <731>"/>
</documentation>
<goalId value="c40aa176-e6aa-4fe4-869d-6550ee992903"/>
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<action id="3510686b-fb93-4980-a41c-0a3754be7f37">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3"/>
</extension>
<prefix value="Single Stage"/>
<title value="Readily Carbonizable Sub"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC6"/>
<display value="Organoleptic"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC22"/>
<display value="Color of solution"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <271>"/>
</documentation>
<goalId value="b122987d-586c-481b-951c-6202e660158d"/>
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<action id="b2e18cc4-f494-4ef0-be34-810d8d4b439b">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="4"/>
</extension>
<prefix value="Single Stage"/>
<title value="Residue on ignition (Ash)"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC38"/>
<display value="Residue on Ignition"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <281>"/>
</documentation>
<goalId value="929747ad-e83a-46f0-bbbc-133ee951e819"/>
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<action id="d315a1c3-dd93-498d-8ae3-dc0d4b3bec75">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="5"/>
</extension>
<prefix value="Single Stage"/>
<title value="Substances insoluble in sodium carbonate TS"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC11"/>
<display value="Foreign and Particulate Matter"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-02"/>
</documentation>
<goalId value="8d7c85c2-7a4b-432e-ac94-226f296e4fca"/>
</action>
<action id="6ec15bbc-a78a-4351-9ad8-fcf97e839ab9">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="6"/>
</extension>
<prefix value="Single Stage"/>
<title value="Impurities - Chloride (Cl)"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="FTIR"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC53"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC92"/>
<display value="Specified identified impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <221>"/>
</documentation>
<goalId value="de4f962a-d486-486d-8d84-f2d1635646b4"/>
</action>
<action id="fa31b425-896c-4b25-b693-ccdd14e0c8ee">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="7"/>
</extension>
<prefix value="Single Stage"/>
<title value="Impurities - Sulfate (SO4)"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="FTIR"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
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<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC53"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC92"/>
<display value="Specified identified impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <221>"/>
</documentation>
<goalId value="b46dce64-a009-46cd-ab95-21d1d5b4df77"/>
</action>
<action id="cef5aa1a-8770-4f78-9bc3-da9f18b77e5c">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="8"/>
</extension>
<prefix value="Single Stage"/>
<title value="Elemental Impurities - Limits"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="UV"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
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<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC53"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC98"/>
<display value="elemental impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <231>"/>
</documentation>
<goalId value="5566f501-37e1-49fb-8783-b20c074ec0c3"/>
</action>
<action id="d5871ee2-8b06-414c-91b4-4b30f5881c8a">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="9"/>
</extension>
<prefix value="Single Stage"/>
<title value="Limit of Free Salicylic Acid"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Titration"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC53"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC100"/>
<display value="Impurities/Degradation Products/Related Substances"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-03"/>
</documentation>
<goalId value="db19e3ab-e28b-4477-8bd7-2409093ed5a3"/>
</action>
<action id="e192fc72-c4b1-419f-8098-6f65037a3962">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="10"/>
</extension>
<prefix value="Single Stage"/>
<title value="Organic Volatile Impurities"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC53"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC101"/>
<display value="residual solvent"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <467>"/>
</documentation>
<goalId value="82370588-7aae-4556-9262-a7f50dbd01aa"/>
<goalId value="cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2"/>
<goalId value="28ad4d5b-d975-4f6e-9792-b3d9cc7ce279"/>
<goalId value="33fa051c-6b3c-4e4d-bd4e-09d39fc253b3"/>
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<action id="b7e88ea0-3c61-49db-86ec-8d01f8b7667b">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="11"/>
</extension>
<prefix value="Single Stage"/>
<title value="Assay Dry Basis"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC1"/>
<display value="Assay"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC2"/>
<display value="active ingredient"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-04"/>
</documentation>
<goalId value="9100e938-42ff-4004-8473-ed5090d66f3a"/>
</action>
<action id="6d1ba5a8-6590-496a-ad6b-ca68cfda2878">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="12"/>
</extension>
<title value="Dissolution - 30 minute"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC9"/>
<display value="Dissolution"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-05"/>
</documentation>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1"/>
</extension>
<linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
<prefix value="Stage 1"/>
<goalId value="af260128-f105-4692-ba40-49f21f12ad46"/>
<goalId value="31d9dcac-bf72-420b-a415-c924155a83f4"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2"/>
</extension>
<linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
<prefix value="Stage 2"/>
<goalId value="47c0d685-0b23-4637-9af8-a554e4fad7ec"/>
<goalId value="14d3dee8-e024-4367-b0a2-a2a809303ee0"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3"/>
</extension>
<linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
<prefix value="Stage 3"/>
<goalId value="15309a78-92a9-4cf9-aee1-452d6d2f7a91"/>
<goalId value="666ace1e-bd29-4263-9ae2-2391106326bb"/>
</action>
</action>
</PlanDefinition>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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