Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot 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-fda/ and changes regularly. See the Directory of published versions
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"title" : "eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll",
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{
"title" : "Impurities for TabletCoatedBeadsCoatedAll",
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🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition ddd3abad-347c-4d2f-95f3-dd804e250502</b></p><a name=\"ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><a name=\"hcddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><a name=\"ddd3abad-347c-4d2f-95f3-dd804e250502-en-US\"> </a><p><b>identifier</b>: TabletCoatedBeadsCoatedAll</p><p><b>description</b>: </p><div><p>A drug product composed of one type of bead with two coatings inside a coated tablet</p>\n</div><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42964}\">TABLET, MULTILAYER</span></p><p><b>route</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}\">ORAL</span></p><h3>Impurities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-58ae52aa-c81e-415a-8791-e67a3195290d\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-ffa30c0b-8031-436a-87f1-635b3bbe5989\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: LEVOTHYROXINE SODIUM ANHYDROUS 125mg</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}\">Non-Proprietary</span></p><blockquote><p><b>part</b></p><p><b>part</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 125mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">LEVOTHYROXINE SODIUM ANHYDROUS</span></p></blockquote></blockquote></div>"
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"impurity" : [
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}
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}
},
{
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"identifier" : [
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"name" : "connectathon_Site",
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"city" : "Danbury",
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"postalCode" : "06811",
"country" : "USA"
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"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 58ae52aa-c81e-415a-8791-e67a3195290d</b></p><a name=\"58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><a name=\"hc58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><a name=\"58ae52aa-c81e-415a-8791-e67a3195290d-en-US\"> </a><p><b>identifier</b>: DCM</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176815}\">Residual Solvent</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title=\"Codes:\">Leftover Solvent</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: YMWUJEATGCHHMB-UHFFFAOYSA-N</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54683}\">InChI File (small molecule)</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: ClCCl</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}\">SMILES</span></p></blockquote></blockquote><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><span title=\"Codes:{http://fdasis.nlm.nih.gov 588X2YUY0A}\">588X2YUY0A</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>DICHLOROMETHANE</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C97054}\">Generic Name</span></td><td>true</td></tr></table></div>"
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}
]
}
],
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}
],
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{
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"code" : [
{
"code" : {
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],
"name" : [
{
"name" : "DICHLOROMETHANE",
"type" : {
"coding" : [
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"code" : "C97054",
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]
},
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}
]
}
},
{
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"id" : "ffa30c0b-8031-436a-87f1-635b3bbe5989",
"meta" : {
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🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition ffa30c0b-8031-436a-87f1-635b3bbe5989</b></p><a name=\"ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><a name=\"hcffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><a name=\"ffa30c0b-8031-436a-87f1-635b3bbe5989-en-US\"> </a><p><b>identifier</b>: hydroxyApatite</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176816}\">Degradation Product</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title=\"Codes:\">formed from dicalcium phosphate degradation</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: XZFUZCHOJLQYHV-UHFFFAOYSA-M</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54683}\">InChI File (small molecule)</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}\">SMILES</span></p></blockquote></blockquote><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><span title=\"Codes:{http://fdasis.nlm.nih.gov 91D9GV0Z28}\">91D9GV0Z28</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>TRIBASIC CALCIUM PHOSPHATE</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table></div>"
},
"identifier" : [
{
"value" : "hydroxyApatite"
}
],
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C176816",
"display" : "Degradation Product"
}
]
}
],
"structure" : {
"technique" : [
{
"text" : "formed from dicalcium phosphate degradation"
}
],
"representation" : [
{
"type" : {
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{
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"representation" : "XZFUZCHOJLQYHV-UHFFFAOYSA-M",
"format" : {
"coding" : [
{
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}
]
}
},
{
"type" : {
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},
"representation" : "[OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O",
"format" : {
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{
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}
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]
},
"code" : [
{
"code" : {
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{
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"code" : "91D9GV0Z28"
}
]
}
}
],
"name" : [
{
"name" : "TRIBASIC CALCIUM PHOSPHATE",
"type" : {
"coding" : [
{
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"code" : "C203355",
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}
]
},
"preferred" : true
}
]
}
}
]
}
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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