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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"title" : "Cochineal specification Composition Example",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </a><p><b>Generated Narrative: PlanDefinition</b><a name=\"37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </a><a name=\"hc37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition "37bf5cc0-33bf-478b-b84e-ccb35143ef6e" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-quality-specification.html\">Quality Specification</a></p></div><p><b>Specification Type</b>: Raw Materials/Excipients/Intermediates/Reagents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C133931)</span></p><p><b>identifier</b>: CochinealSpecification</p><p><b>version</b>: 1.0</p><p><b>title</b>: Cochineal specification Example</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48660 "Not Applicable")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf</p><p><b>date</b>: 2023-12-01</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>e900181a-876c-4ed6-ac96-d5a73c3d6767</blockquote><p><b>description</b>: White Solid <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>White solid <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c</blockquote><p><b>description</b>: IR spectrum conforms to reference standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>IR spectrum conforms to reference standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>1f476689-f440-4a77-9e9c-0615af3571eb</blockquote><p><b>description</b>: pH 3.4-4.3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>3.4-4.3 [pH]</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>9c0d2619-4505-4e6b-a801-bc30f84bc3e2</blockquote><p><b>description</b>: residue <= 0.21% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.21 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>fc230a97-fd1a-4017-8603-822c5430a217</blockquote><p><b>description</b>: Formaldehyde NMT 1.5% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>1.5 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>8d6688e0-7412-4d64-afe8-b73d8aec596e</blockquote><p><b>description</b>: Impurity C NMT 2% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>f8e8343d-a37d-4b91-916b-f58d6947dc9c</blockquote><p><b>description</b>: Unspecified Impurity NMT 0.10 % w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.1 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>be7abaa1-0769-4560-af76-326e07d1df9a</blockquote><p><b>description</b>: Total Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.7 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>cfdd469d-020b-4047-946f-f513d58f007f</blockquote><p><b>description</b>: Total Unidentified Impurities NMT 0.3% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.3 %<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>c5eea380-416f-4d19-a21e-c021f3c7c543</blockquote><p><b>description</b>: RRT 2.2 NMT 0.10% w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.1 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>41e19fa2-f568-443e-8bc1-6b0a6dca9d0c</blockquote><p><b>description</b>: RRT 2.4 NMT 0.10% w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.1 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>e493cb3d-45b6-4463-b9b6-e588c51e032c</blockquote><p><b>description</b>: RRT 3.41 NMT 0.10% w/w <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>0.2 %{WeightToWeight}<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>linkId</b>: b9359ce8-73f3-45c5-9674-98d850053aa2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Appearance</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Organoleptic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC6)</span>, Description/Appearance <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#SUBC20)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-101</td></tr></table><p><b>goalId</b>: e900181a-876c-4ed6-ac96-d5a73c3d6767</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>linkId</b>: 443ed163-7a7b-4d48-9462-be5532158411</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Identification</p><p><b>code</b>: FTIR <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 "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-102</td></tr></table><p><b>goalId</b>: 21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>linkId</b>: 058193ee-dd86-4c63-9f47-7b0608abbca4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: pH</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: pH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC23)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-103</td></tr></table><p><b>goalId</b>: 1f476689-f440-4a77-9e9c-0615af3571eb</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>linkId</b>: 940c8db4-9ed1-416e-84ec-9f9e143be8ab</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Residue on Ignition</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96102 "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>: 9c0d2619-4505-4e6b-a801-bc30f84bc3e2</p></blockquote><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 5</p><p><b>linkId</b>: 9fca0a37-6d10-4273-a966-c026ab6eb07d</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Impurities</p><p><b>code</b>: FTIR <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96103 "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></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>EX-TEST-104</td></tr></table><p><b>goalId</b>: fc230a97-fd1a-4017-8603-822c5430a217, 8d6688e0-7412-4d64-afe8-b73d8aec596e, f8e8343d-a37d-4b91-916b-f58d6947dc9c, be7abaa1-0769-4560-af76-326e07d1df9a, cfdd469d-020b-4047-946f-f513d58f007f</p><blockquote><p><b>action</b></p><p><b>Test Order | Stage Sequence Order</b>: 5.1</p><p><b>title</b>: Unidentified Impurities</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>"
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},
{
"fullUrl" : "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "278736ef-2ddf-49e4-895c-3a9f34db36cf",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><a name=\"hc278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition "278736ef-2ddf-49e4-895c-3a9f34db36cf" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Cochineal</p><p><b>classification</b>: Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>grade</b>: Company Standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134009)</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>TZ8Z31B35M <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#TZ8Z31B35M)</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>Cochineal</td><td>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C203355)</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td>Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></td><td>Dactylopius <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>cochineal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>Turkey <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#TUR)</span></td></tr></table></div>"
},
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{
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}
],
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{
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{
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"code" : "C48807",
"display" : "Chemical"
}
]
}
],
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{
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"code" : "C134009",
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}
]
}
],
"code" : [
{
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{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "TZ8Z31B35M"
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}
}
],
"name" : [
{
"name" : "Cochineal",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C203355",
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],
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{
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"code" : "C48807",
"display" : "Chemical"
}
]
},
"genus" : {
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},
"species" : {
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},
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{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "TUR",
"display" : "Turkey"
}
]
}
]
}
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},
{
"fullUrl" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a",
"resource" : {
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"id" : "4f3e9af1-306b-4fad-bf04-7881400b266a",
"meta" : {
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🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization"
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"text" : {
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"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>"
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},
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"contact" : [
{
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"line" : [
"123 Scenic Road"
],
"city" : "Bridgeport",
"state" : "CT",
"postalCode" : "65478",
"country" : "USA"
}
}
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}
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}
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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