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 |
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:PlanDefinition ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "aa514363-d43f-4052-b44e-b67aa4d6dee7"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><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>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134021" ] ; fhir:display [ fhir:v "Drug Product" ] ] ) ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ; fhir:value [ fhir:v "brr" ] ] ) ; # fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7"^^xsd:anyURI] ; # fhir:identifier ( [ fhir:value [ fhir:v "ExampleSpecification" ] ] ) ; # fhir:version [ fhir:v "0.1.20"] ; # fhir:title [ fhir:v "Quality Specification for Buffered Asprin"] ; # fhir:status [ fhir:v "active"] ; # fhir:subject [ a fhir:Reference ; fhir:reference [ fhir:v "urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9" ] ] ; # fhir:date [ fhir:v "2022-12-08"^^xsd:date] ; # fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # fhir:contact ( [ fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ; ( fhir:telecom [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "brr@lists.HL7.org" ] ] ) ] ) ; # fhir:useContext ( [ fhir:code [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/usage-context-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "workflow" ] ; fhir:display [ fhir:v "Workflow Setting" ] ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134011" ] ; fhir:display [ fhir:v "Not Approved" ] ] ) ] ] ) ; # fhir:jurisdiction ( [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "US" ] ; fhir:display [ fhir:v "United States of America" ] ] ) ] ) ; # fhir:goal ( [ fhir:id [ fhir:v "32649771-1290-4386-9cf7-7a72274f22b4" ] ; fhir:description [ fhir:text [ fhir:v "Average of 10 between 2-3 pH" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Range ; fhir:low [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61583" ] ; fhir:display [ fhir:v "NLT (not less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "2"^^xsd:decimal ] ; fhir:unit [ fhir:v "pH" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C45997" ] ] ; fhir:high [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61585" ] ; fhir:display [ fhir:v "LT (less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "3"^^xsd:decimal ] ; fhir:unit [ fhir:v "pH" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C45997" ] ] ] ] ) ] [ fhir:id [ fhir:v "59a4ca76-858e-4d58-8e5f-88e75f51ec33" ] ; fhir:description [ fhir:text [ fhir:v "Maxima only at the same wavelengths compared to reference standard" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "Conforms" ] ] ] ) ] [ fhir:id [ fhir:v "c40aa176-e6aa-4fe4-869d-6550ee992903" ] ; fhir:description [ fhir:text [ fhir:v "<= 0.5 %" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.5"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "b122987d-586c-481b-951c-6202e660158d" ] ; fhir:description [ fhir:text [ fhir:v "Color of solution is clear" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "Conforms" ] ] ] ) ] [ fhir:id [ fhir:v "929747ad-e83a-46f0-bbbc-133ee951e819" ] ; fhir:description [ fhir:text [ fhir:v "<= 0.05 %" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.05"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "8d7c85c2-7a4b-432e-ac94-226f296e4fca" ] ; fhir:description [ fhir:text [ fhir:v "No Particulate Matter detected" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "pass" ] ] ] ) ] [ fhir:id [ fhir:v "de4f962a-d486-486d-8d84-f2d1635646b4" ] ; fhir:description [ fhir:text [ fhir:v "<= 0.014 %" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.014"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "b46dce64-a009-46cd-ab95-21d1d5b4df77" ] ; fhir:description [ fhir:text [ fhir:v "<= 0.04 %" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.04"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "5566f501-37e1-49fb-8783-b20c074ec0c3" ] ; fhir:description [ fhir:text [ fhir:v "<= 0.001 %" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.001"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "db19e3ab-e28b-4477-8bd7-2409093ed5a3" ] ; fhir:description [ fhir:text [ fhir:v "Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "pass" ] ] ] ) ] [ fhir:id [ fhir:v "82370588-7aae-4556-9262-a7f50dbd01aa" ] ; fhir:description [ fhir:text [ fhir:v "Ethanol < 0.2%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:measure [ fhir:text [ fhir:v "Ethanol" ] ] ; fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61585" ] ; fhir:display [ fhir:v "LT (less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.2"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2" ] ; fhir:description [ fhir:text [ fhir:v "Ethyl Ether < 0.1%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] ) ; ( fhir:target [ fhir:measure [ fhir:text [ fhir:v "Ethyl Ether" ] ] ; fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61585" ] ; fhir:display [ fhir:v "LT (less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.1"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "28ad4d5b-d975-4f6e-9792-b3d9cc7ce279" ] ; fhir:description [ fhir:text [ fhir:v "1—propanol < 0.15%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] ) ; ( fhir:target [ fhir:measure [ fhir:text [ fhir:v "1—propanol" ] ] ; fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61585" ] ; fhir:display [ fhir:v "LT (less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.15"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "33fa051c-6b3c-4e4d-bd4e-09d39fc253b3" ] ; fhir:description [ fhir:text [ fhir:v "Total < 0.5%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] ) ; ( fhir:target [ fhir:measure [ fhir:text [ fhir:v "Total Residual Solvents" ] ] ; fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61585" ] ; fhir:display [ fhir:v "LT (less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0.5"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "9100e938-42ff-4004-8473-ed5090d66f3a" ] ; fhir:description [ fhir:text [ fhir:v "99.5 - 100.5 %" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Range ; fhir:low [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61583" ] ; fhir:display [ fhir:v "NLT (not less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "99.5"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ; fhir:high [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "100.5"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ] ) ] [ fhir:id [ fhir:v "af260128-f105-4692-ba40-49f21f12ad46" ] ; fhir:description [ fhir:text [ fhir:v "n=6" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ fhir:v "6"^^xsd:integer ] ] ) ] [ fhir:id [ fhir:v "31d9dcac-bf72-420b-a415-c924155a83f4" ] ; fhir:description [ fhir:text [ fhir:v "Each unit is NLT Q + 5%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61583" ] ; fhir:display [ fhir:v "NLT (not less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "85"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "47c0d685-0b23-4637-9af8-a554e4fad7ec" ] ; fhir:description [ fhir:text [ fhir:v "n=6" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ fhir:v "6"^^xsd:integer ] ] ) ] [ fhir:id [ fhir:v "14d3dee8-e024-4367-b0a2-a2a809303ee0" ] ; fhir:description [ fhir:text [ fhir:v "Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q – 15%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] ) ; ( fhir:target [ fhir:measure [ fhir:text [ fhir:v "Average of 12 units" ] ] ; fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61583" ] ; fhir:display [ fhir:v "NLT (not less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "80"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] [ fhir:measure [ fhir:text [ fhir:v "unit" ] ] ; fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61585" ] ; fhir:display [ fhir:v "LT (less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "65"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "15309a78-92a9-4cf9-aee1-452d6d2f7a91" ] ; fhir:description [ fhir:text [ fhir:v "Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q – 15%, no unit is less than Q – 25%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] ) ; ( fhir:target [ fhir:measure [ fhir:text [ fhir:v "Average of 24 units" ] ] ; fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61583" ] ; fhir:display [ fhir:v "NLT (not less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "80"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] [ fhir:measure [ fhir:text [ fhir:v "units less than Q – 15%" ] ] ; fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61583" ] ; fhir:display [ fhir:v "NLT (not less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "2"^^xsd:decimal ] ; fhir:unit [ fhir:v "amb a 1 units" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C92953" ] ] ] [ fhir:measure [ fhir:text [ fhir:v "units less than Q – 25%" ] ] ; fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61585" ] ; fhir:display [ fhir:v "LT (less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "0"^^xsd:decimal ] ; fhir:unit [ fhir:v "amb a 1 units" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C92953" ] ] ] ) ] [ fhir:id [ fhir:v "666ace1e-bd29-4263-9ae2-2391106326bb" ] ; fhir:description [ fhir:text [ fhir:v "n=12" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ fhir:v "12"^^xsd:integer ] ] ) ] ) ; # fhir:action ( [ fhir:id [ fhir:v "2047a6b6-e3fc-4071-8989-526297579091" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1.1"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Spectrophotometry Identification" ] ; fhir:description [ fhir:v "Alternate" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96102" ] ; fhir:display [ fhir:v "Compendial" ] ] ) ; fhir:text [ fhir:v "Spectrophotometry" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC7" ] ; fhir:display [ fhir:v "Identification" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "USP <197>" ] ] ) ; ( fhir:goalId [ fhir:v "32649771-1290-4386-9cf7-7a72274f22b4" ] ) ; ( fhir:relatedAction [ fhir:targetId [ fhir:v "84d64dd8-b799-418a-a713-a854c4d3c2b9" ] ; fhir:relationship [ fhir:v "concurrent" ] ] ) ; fhir:selectionBehavior [ fhir:v "exactly-one" ] ] [ fhir:id [ fhir:v "84d64dd8-b799-418a-a713-a854c4d3c2b9" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1.2"^^xsd:decimal ] ] ) ; fhir:linkId [ fhir:v "2047a6b6-e3fc-4071-8989-526297579091" ] ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Identity - Ferric Chloride" ] ; fhir:description [ fhir:v "Alternate" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "HPLC" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC7" ] ; fhir:display [ fhir:v "Identification" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-01" ] ] ) ; ( fhir:goalId [ fhir:v "59a4ca76-858e-4d58-8e5f-88e75f51ec33" ] ) ; ( fhir:relatedAction [ fhir:targetId [ fhir:v "2047a6b6-e3fc-4071-8989-526297579091" ] ; fhir:relationship [ fhir:v "concurrent" ] ] ) ; fhir:selectionBehavior [ fhir:v "exactly-one" ] ] [ fhir:id [ fhir:v "838e66ce-f4b0-47a5-8ea0-aa7882a84303" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Loss on Drying" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96102" ] ; fhir:display [ fhir:v "Compendial" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC12" ] ; fhir:display [ fhir:v "Loss on Drying" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "USP <731>" ] ] ) ; ( fhir:goalId [ fhir:v "c40aa176-e6aa-4fe4-869d-6550ee992903" ] ) ] [ fhir:id [ fhir:v "3510686b-fb93-4980-a41c-0a3754be7f37" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "3"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Readily Carbonizable Sub" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96102" ] ; fhir:display [ fhir:v "Compendial" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC6" ] ; fhir:display [ fhir:v "Organoleptic" ] ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "SUBC22" ] ; fhir:display [ fhir:v "Color of solution" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "USP <271>" ] ] ) ; ( fhir:goalId [ fhir:v "b122987d-586c-481b-951c-6202e660158d" ] ) ] [ fhir:id [ fhir:v "b2e18cc4-f494-4ef0-be34-810d8d4b439b" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "4"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Residue on ignition (Ash)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96102" ] ; fhir:display [ fhir:v "Compendial" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC38" ] ; fhir:display [ fhir:v "Residue on Ignition" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "USP <281>" ] ] ) ; ( fhir:goalId [ fhir:v "929747ad-e83a-46f0-bbbc-133ee951e819" ] ) ] [ fhir:id [ fhir:v "d315a1c3-dd93-498d-8ae3-dc0d4b3bec75" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "5"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Substances insoluble in sodium carbonate TS" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC11" ] ; fhir:display [ fhir:v "Foreign and Particulate Matter" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-02" ] ] ) ; ( fhir:goalId [ fhir:v "8d7c85c2-7a4b-432e-ac94-226f296e4fca" ] ) ] [ fhir:id [ fhir:v "6ec15bbc-a78a-4351-9ad8-fcf97e839ab9" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "6"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Impurities - Chloride (Cl)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96102" ] ; fhir:display [ fhir:v "Compendial" ] ] ) ; fhir:text [ fhir:v "FTIR" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC53" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "SUBC92" ] ; fhir:display [ fhir:v "Specified identified impurity" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "USP <221>" ] ] ) ; ( fhir:goalId [ fhir:v "de4f962a-d486-486d-8d84-f2d1635646b4" ] ) ] [ fhir:id [ fhir:v "fa31b425-896c-4b25-b693-ccdd14e0c8ee" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "7"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Impurities - Sulfate (SO4)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96102" ] ; fhir:display [ fhir:v "Compendial" ] ] ) ; fhir:text [ fhir:v "FTIR" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC53" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "SUBC92" ] ; fhir:display [ fhir:v "Specified identified impurity" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "USP <221>" ] ] ) ; ( fhir:goalId [ fhir:v "b46dce64-a009-46cd-ab95-21d1d5b4df77" ] ) ] [ fhir:id [ fhir:v "cef5aa1a-8770-4f78-9bc3-da9f18b77e5c" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "8"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Elemental Impurities - Limits" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96102" ] ; fhir:display [ fhir:v "Compendial" ] ] ) ; fhir:text [ fhir:v "UV" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC53" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "SUBC98" ] ; fhir:display [ fhir:v "elemental impurity" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "USP <231>" ] ] ) ; ( fhir:goalId [ fhir:v "5566f501-37e1-49fb-8783-b20c074ec0c3" ] ) ] [ fhir:id [ fhir:v "d5871ee2-8b06-414c-91b4-4b30f5881c8a" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "9"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Limit of Free Salicylic Acid" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Titration" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC53" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "SUBC100" ] ; fhir:display [ fhir:v "Impurities/Degradation Products/Related Substances" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-03" ] ] ) ; ( fhir:goalId [ fhir:v "db19e3ab-e28b-4477-8bd7-2409093ed5a3" ] ) ] [ fhir:id [ fhir:v "e192fc72-c4b1-419f-8098-6f65037a3962" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "10"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Organic Volatile Impurities" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96102" ] ; fhir:display [ fhir:v "Compendial" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC53" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "SUBC101" ] ; fhir:display [ fhir:v "residual solvent" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "USP <467>" ] ] ) ; ( fhir:goalId [ fhir:v "82370588-7aae-4556-9262-a7f50dbd01aa" ] [ fhir:v "cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2" ] [ fhir:v "28ad4d5b-d975-4f6e-9792-b3d9cc7ce279" ] [ fhir:v "33fa051c-6b3c-4e4d-bd4e-09d39fc253b3" ] ) ] [ fhir:id [ fhir:v "b7e88ea0-3c61-49db-86ec-8d01f8b7667b" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "11"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Assay Dry Basis" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC1" ] ; fhir:display [ fhir:v "Assay" ] ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "SUBC2" ] ; fhir:display [ fhir:v "active ingredient" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-04" ] ] ) ; ( fhir:goalId [ fhir:v "9100e938-42ff-4004-8473-ed5090d66f3a" ] ) ] [ fhir:id [ fhir:v "6d1ba5a8-6590-496a-ad6b-ca68cfda2878" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "12"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Dissolution - 30 minute" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC9" ] ; fhir:display [ fhir:v "Dissolution" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-05" ] ] ) ; ( fhir:action [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:decimal ] ] ) ; fhir:linkId [ fhir:v "6d1ba5a8-6590-496a-ad6b-ca68cfda2878" ] ; fhir:prefix [ fhir:v "Stage 1" ] ; ( fhir:goalId [ fhir:v "af260128-f105-4692-ba40-49f21f12ad46" ] [ fhir:v "31d9dcac-bf72-420b-a415-c924155a83f4" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:decimal ] ] ) ; fhir:linkId [ fhir:v "6d1ba5a8-6590-496a-ad6b-ca68cfda2878" ] ; fhir:prefix [ fhir:v "Stage 2" ] ; ( fhir:goalId [ fhir:v "47c0d685-0b23-4637-9af8-a554e4fad7ec" ] [ fhir:v "14d3dee8-e024-4367-b0a2-a2a809303ee0" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "3"^^xsd:decimal ] ] ) ; fhir:linkId [ fhir:v "6d1ba5a8-6590-496a-ad6b-ca68cfda2878" ] ; fhir:prefix [ fhir:v "Stage 3" ] ; ( fhir:goalId [ fhir:v "15309a78-92a9-4cf9-aee1-452d6d2f7a91" ] [ fhir:v "666ace1e-bd29-4263-9ae2-2391106326bb" ] ) ] ) ] ) . #
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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