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
| Active as of 2024-12-04 |
{
"resourceType" : "ValueSet",
"id" : "pqcmc-excipient-function-terminology",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet pqcmc-excipient-function-terminology</b></p><a name=\"pqcmc-excipient-function-terminology\"> </a><a name=\"hcpqcmc-excipient-function-terminology\"> </a><a name=\"pqcmc-excipient-function-terminology-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C176637</td><td>Absorption modifier</td></tr><tr><td>C89528</td><td>Adhesive</td></tr><tr><td>C176642</td><td>Adsorbent</td></tr><tr><td>C176643</td><td>Air displacement</td></tr><tr><td>C275</td><td>Antioxidant</td></tr><tr><td>C42647</td><td>Binder</td></tr><tr><td>C70815</td><td>Buffering agent</td></tr><tr><td>C176644</td><td>Bulking agent</td></tr><tr><td>C176645</td><td>Carrier</td></tr><tr><td>C360</td><td>Chelating agent</td></tr><tr><td>C42656</td><td>Coloring agent</td></tr><tr><td>C176646</td><td>Complexing agent</td></tr><tr><td>C53306</td><td>Cryoprotectant</td></tr><tr><td>C176647</td><td>Denaturant</td></tr><tr><td>C42648</td><td>Disintegrant</td></tr><tr><td>C42662</td><td>Dispersing agent</td></tr><tr><td>C927</td><td>Vehicle</td></tr><tr><td>C176638</td><td>Effervescent agent</td></tr><tr><td>C176632</td><td>Emollient</td></tr><tr><td>C73477</td><td>Emulsifying Excipient</td></tr><tr><td>C176633</td><td>Emulsion stabilizing agent</td></tr><tr><td>C42650</td><td>Filler</td></tr><tr><td>C176648</td><td>Film coating agent</td></tr><tr><td>C176634</td><td>Foam stabilizing agent</td></tr><tr><td>C176649</td><td>Free radical scavenger</td></tr><tr><td>C176650</td><td>Gelling agent</td></tr><tr><td>C42654</td><td>Anticaking agent</td></tr><tr><td>C176651</td><td>Humectant</td></tr><tr><td>C42653</td><td>Lubricant</td></tr><tr><td>C176652</td><td>Lyophilization aid</td></tr><tr><td>C176653</td><td>Matrix-forming agent</td></tr><tr><td>C176654</td><td>Microencapsulating agent</td></tr><tr><td>C176655</td><td>Ointment base</td></tr><tr><td>C176656</td><td>Opacifier</td></tr><tr><td>C176660</td><td>Polymers for ophthalmic use</td></tr><tr><td>C176635</td><td>Organoleptic agent</td></tr><tr><td>C176657</td><td>Osmotic agent</td></tr><tr><td>C55826</td><td>Plasticizer</td></tr><tr><td>C176659</td><td>Polishing agent</td></tr><tr><td>C42659</td><td>Preservative</td></tr><tr><td>C42657</td><td>Ink</td></tr><tr><td>C176661</td><td>Propellant</td></tr><tr><td>C176639</td><td>Reducing agent</td></tr><tr><td>C176662</td><td>Release modifying agent</td></tr><tr><td>C176640</td><td>Solubilizing agent</td></tr><tr><td>C45790</td><td>Solvent</td></tr><tr><td>C176636</td><td>Stabilizer</td></tr><tr><td>C176663</td><td>Suppository base</td></tr><tr><td>C42739</td><td>Surfactant</td></tr><tr><td>C42660</td><td>Suspending agent</td></tr><tr><td>C176641</td><td>Tonicity agent</td></tr><tr><td>C176664</td><td>Transdermal delivery component</td></tr><tr><td>C176665</td><td>Transfer ligand</td></tr><tr><td>C176666</td><td>Viscosity modifier</td></tr><tr><td>C176667</td><td>Water-repelling agent</td></tr><tr><td>C176668</td><td>Wetting agent</td></tr><tr><td>C176658</td><td>pH modifier</td></tr></table></li></ul></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}
],
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology",
"identifier" : [
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.36.48.11"
}
],
"version" : "2.0.0-ballot",
"name" : "PqcmcExcipientFunctionTerminology",
"title" : "Excipient Function Terminology",
"status" : "active",
"experimental" : false,
"date" : "2024-12-04T20:50:29+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International / Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
},
{
"system" : "email",
"value" : "brr@lists.HL7.org"
}
]
}
],
"description" : "Terminology used to qualify the information pertaining to excipient functions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "US",
"display" : "United States of America"
}
]
}
],
"compose" : {
"include" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"concept" : [
{
"code" : "C176637",
"display" : "Absorption modifier"
},
{
"code" : "C89528",
"display" : "Adhesive"
},
{
"code" : "C176642",
"display" : "Adsorbent"
},
{
"code" : "C176643",
"display" : "Air displacement"
},
{
"code" : "C275",
"display" : "Antioxidant"
},
{
"code" : "C42647",
"display" : "Binder"
},
{
"code" : "C70815",
"display" : "Buffering agent"
},
{
"code" : "C176644",
"display" : "Bulking agent"
},
{
"code" : "C176645",
"display" : "Carrier"
},
{
"code" : "C360",
"display" : "Chelating agent"
},
{
"code" : "C42656",
"display" : "Coloring agent"
},
{
"code" : "C176646",
"display" : "Complexing agent"
},
{
"code" : "C53306",
"display" : "Cryoprotectant"
},
{
"code" : "C176647",
"display" : "Denaturant"
},
{
"code" : "C42648",
"display" : "Disintegrant"
},
{
"code" : "C42662",
"display" : "Dispersing agent"
},
{
"code" : "C927",
"display" : "Vehicle"
},
{
"code" : "C176638",
"display" : "Effervescent agent"
},
{
"code" : "C176632",
"display" : "Emollient"
},
{
"code" : "C73477",
"display" : "Emulsifying Excipient"
},
{
"code" : "C176633",
"display" : "Emulsion stabilizing agent"
},
{
"code" : "C42650",
"display" : "Filler"
},
{
"code" : "C176648",
"display" : "Film coating agent"
},
{
"code" : "C176634",
"display" : "Foam stabilizing agent"
},
{
"code" : "C176649",
"display" : "Free radical scavenger"
},
{
"code" : "C176650",
"display" : "Gelling agent"
},
{
"code" : "C42654",
"display" : "Anticaking agent"
},
{
"code" : "C176651",
"display" : "Humectant"
},
{
"code" : "C42653",
"display" : "Lubricant"
},
{
"code" : "C176652",
"display" : "Lyophilization aid"
},
{
"code" : "C176653",
"display" : "Matrix-forming agent"
},
{
"code" : "C176654",
"display" : "Microencapsulating agent"
},
{
"code" : "C176655",
"display" : "Ointment base"
},
{
"code" : "C176656",
"display" : "Opacifier"
},
{
"code" : "C176660",
"display" : "Polymers for ophthalmic use"
},
{
"code" : "C176635",
"display" : "Organoleptic agent"
},
{
"code" : "C176657",
"display" : "Osmotic agent"
},
{
"code" : "C55826",
"display" : "Plasticizer"
},
{
"code" : "C176659",
"display" : "Polishing agent"
},
{
"code" : "C42659",
"display" : "Preservative"
},
{
"code" : "C42657",
"display" : "Ink"
},
{
"code" : "C176661",
"display" : "Propellant"
},
{
"code" : "C176639",
"display" : "Reducing agent"
},
{
"code" : "C176662",
"display" : "Release modifying agent"
},
{
"code" : "C176640",
"display" : "Solubilizing agent"
},
{
"code" : "C45790",
"display" : "Solvent"
},
{
"code" : "C176636",
"display" : "Stabilizer"
},
{
"code" : "C176663",
"display" : "Suppository base"
},
{
"code" : "C42739",
"display" : "Surfactant"
},
{
"code" : "C42660",
"display" : "Suspending agent"
},
{
"code" : "C176641",
"display" : "Tonicity agent"
},
{
"code" : "C176664",
"display" : "Transdermal delivery component"
},
{
"code" : "C176665",
"display" : "Transfer ligand"
},
{
"code" : "C176666",
"display" : "Viscosity modifier"
},
{
"code" : "C176667",
"display" : "Water-repelling agent"
},
{
"code" : "C176668",
"display" : "Wetting agent"
},
{
"code" : "C176658",
"display" : "pH modifier"
}
]
}
]
}
}
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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