Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
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{
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_aa514363-d43f-4052-b44e-b67aa4d6dee7\"> </a><p><b>Generated Narrative: PlanDefinition</b><a name=\"aa514363-d43f-4052-b44e-b67aa4d6dee7\"> </a><a name=\"hcaa514363-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\">PQ-CMC-FDA Temporary Codes</a>#C134021)</span></p><p><b>identifier</b>: ExampleSpecification</p><p><b>version</b>: 1.0</p><p><b>title</b>: Quality Specification for OXAZEPAM</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134011 "Not Approved")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9</p><p><b>date</b>: 2022-12-08</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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2-3 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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Conforms <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.5 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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Conforms <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.05 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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>pass <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.014 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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.04 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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.001 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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>pass <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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; 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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>"
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"display" : "Impurity"
}
]
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}
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"code" : "SUBC92",
"display" : "Specified identified impurity"
}
]
}
],
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"valueDecimal" : 8
}
],
"prefix" : "Single Stage",
"title" : "Elemental Impurities - Limits",
"code" : {
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{
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"code" : "C96102",
"display" : "Compendial"
}
],
"text" : "UV"
},
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}
],
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}
],
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"title" : "Limit of Free Salicylic Acid",
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{
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"code" : "C96103",
"display" : "Proprietary"
}
],
"text" : "Titration"
},
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}
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}
],
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{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
"code" : "SUBC100",
"display" : "Impurities/Degradation Products/Related Substances"
}
]
}
],
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}
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"valueDecimal" : 10
}
],
"prefix" : "Single Stage",
"title" : "Organic Volatile Impurities",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C96102",
"display" : "Compendial"
}
],
"text" : "Visual"
},
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{
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}
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{
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"display" : "Impurity"
}
]
},
{
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{
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"valueInteger" : 2
}
],
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
"code" : "SUBC101",
"display" : "residual solvent"
}
]
}
],
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],
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"28ad4d5b-d975-4f6e-9792-b3d9cc7ce279",
"33fa051c-6b3c-4e4d-bd4e-09d39fc253b3"
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"valueDecimal" : 11
}
],
"prefix" : "Single Stage",
"title" : "Assay Dry Basis",
"code" : {
"coding" : [
{
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"code" : "C96103",
"display" : "Proprietary"
}
],
"text" : "Visual"
},
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{
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}
],
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
"code" : "TC1",
"display" : "Assay"
}
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
"valueInteger" : 2
}
],
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
"code" : "SUBC2",
"display" : "active ingredient"
}
]
}
],
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{
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"label" : "EX-TEST-04"
}
],
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"9100e938-42ff-4004-8473-ed5090d66f3a"
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},
{
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"extension" : [
{
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"valueDecimal" : 12
}
],
"title" : "Dissolution - 30 minute",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C96103",
"display" : "Proprietary"
}
],
"text" : "Visual"
},
"reason" : [
{
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{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
"valueInteger" : 1
}
],
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
"code" : "TC9",
"display" : "Dissolution"
}
]
}
],
"documentation" : [
{
"type" : "documentation",
"label" : "EX-TEST-05"
}
],
"action" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 1
}
],
"linkId" : "6d1ba5a8-6590-496a-ad6b-ca68cfda2878",
"prefix" : "Stage 1",
"goalId" : [
"af260128-f105-4692-ba40-49f21f12ad46",
"31d9dcac-bf72-420b-a415-c924155a83f4"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 2
}
],
"linkId" : "6d1ba5a8-6590-496a-ad6b-ca68cfda2878",
"prefix" : "Stage 2",
"goalId" : [
"47c0d685-0b23-4637-9af8-a554e4fad7ec",
"14d3dee8-e024-4367-b0a2-a2a809303ee0"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 3
}
],
"linkId" : "6d1ba5a8-6590-496a-ad6b-ca68cfda2878",
"prefix" : "Stage 3",
"goalId" : [
"15309a78-92a9-4cf9-aee1-452d6d2f7a91",
"666ace1e-bd29-4263-9ae2-2391106326bb"
]
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "89676a69-1fe7-422c-ab00-92abe4ef6ea9",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-product"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><a name=\"hc89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </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 MedicinalProductDefinition "89676a69-1fe7-422c-ab00-92abe4ef6ea9" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-routine-drug-product.html\">Routine Drug Product</a></p></div><p><b>identifier</b>: Example2BeadDrug</p><p><b>combinedPharmaceuticalDoseForm</b>: CAPSULE <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C25158)</span></p><p><b>route</b>: ORAL <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C38288)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg</p><p><b>type</b>: Non-Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-product-name-types.html\">Product Name Types Code Types</a>#NON)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: OXAZEPAM</p><p><b>type</b>: scientific name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 30mg</p><p><b>type</b>: strength name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: PROPRANOLOL HYDROCHLORIDE</p><p><b>type</b>: scientific name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 60mg</p><p><b>type</b>: strength name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote></blockquote></div>"
},
"identifier" : [
{
"value" : "Example2BeadDrug"
}
],
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C25158",
"display" : "CAPSULE"
}
]
},
"route" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C38288",
"display" : "ORAL"
}
]
}
],
"name" : [
{
"productName" : "OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types",
"code" : "NON",
"display" : "Non-Proprietary"
}
],
"text" : "Non-Proprietary"
},
"part" : [
{
"part" : "OXAZEPAM",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "SCI"
}
]
}
},
{
"part" : "30mg",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "STR"
}
]
}
},
{
"part" : "PROPRANOLOL HYDROCHLORIDE",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "SCI"
}
]
}
},
{
"part" : "60mg",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "STR"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a",
"resource" : {
"resourceType" : "Organization",
"id" : "4f3e9af1-306b-4fad-bf04-7881400b266a",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><p><b>Generated Narrative: Organization</b><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "4f3e9af1-306b-4fad-bf04-7881400b266a" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-sponsor-organization.html\">Sponsor Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>"
},
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134003",
"display" : "DUNS"
}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "143265222"
}
],
"name" : "Wunderwerke",
"contact" : [
{
"address" : {
"text" : "Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478",
"line" : [
"123 Scenic Road"
],
"city" : "Bridgeport",
"state" : "CT",
"postalCode" : "65478",
"country" : "USA"
}
}
]
}
}
]
}
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
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