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
| Active as of 2024-04-08 |
{
"resourceType" : "ValueSet",
"id" : "pqcmc-excipient-function-terminology",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>Include these codes as defined in <a href=\"CodeSystem-cmc-ncit-dummy.html\"><code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176637\">C176637</a></td><td>Absorption Modifying Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C89528\">C89528</a></td><td>Adhesive Device</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176642\">C176642</a></td><td>Adsorbent</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176643\">C176643</a></td><td>Air Displacement Agent</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C275\">C275</a></td><td>Antioxidant</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42647\">C42647</a></td><td>Binder Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C70815\">C70815</a></td><td>Buffer</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176644\">C176644</a></td><td>Bulking Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176645\">C176645</a></td><td>Carrier Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C360\">C360</a></td><td>Chelating Agent</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42656\">C42656</a></td><td>Color Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176646\">C176646</a></td><td>Complexing Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C53306\">C53306</a></td><td>Cryoprotective Agent</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176647\">C176647</a></td><td>Denaturant</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42648\">C42648</a></td><td>Disintegrant Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42662\">C42662</a></td><td>Dispersing Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C927\">C927</a></td><td>Drug Vehicle</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176638\">C176638</a></td><td>Effervescent Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176632\">C176632</a></td><td>Emollient Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C73477\">C73477</a></td><td>Emulsifying Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176633\">C176633</a></td><td>Emulsion Stabilizing Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42650\">C42650</a></td><td>Filler Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176648\">C176648</a></td><td>Film Coating Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176634\">C176634</a></td><td>Foam Stabilizing Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176649\">C176649</a></td><td>Free Radical Scavenging Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176650\">C176650</a></td><td>Gelling Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42654\">C42654</a></td><td>Glidant Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176651\">C176651</a></td><td>Humectant Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42653\">C42653</a></td><td>Lubricant Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176652\">C176652</a></td><td>Lyophilization Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176653\">C176653</a></td><td>Matrix Forming Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176654\">C176654</a></td><td>Microencapsulating Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176655\">C176655</a></td><td>Ointment Base</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176656\">C176656</a></td><td>Opacifying Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176660\">C176660</a></td><td>Ophthalmic Polymer</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176635\">C176635</a></td><td>Organoleptic Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176657\">C176657</a></td><td>Osmotic Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C55826\">C55826</a></td><td>Plasticizer</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176659\">C176659</a></td><td>Polishing Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42659\">C42659</a></td><td>Preservative Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42657\">C42657</a></td><td>Printing Ink Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176661\">C176661</a></td><td>Propellant</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176639\">C176639</a></td><td>Reducing Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176662\">C176662</a></td><td>Release Modifying Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176640\">C176640</a></td><td>Solubilizing Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C45790\">C45790</a></td><td>Solvent</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176636\">C176636</a></td><td>Stabilizing Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176663\">C176663</a></td><td>Suppository Base</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42739\">C42739</a></td><td>Surfactant Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42660\">C42660</a></td><td>Suspending Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176641\">C176641</a></td><td>Tonicity Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176664\">C176664</a></td><td>Transdermal Delivery Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176665\">C176665</a></td><td>Transfer Ligand Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176666\">C176666</a></td><td>Viscosity Modifying Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176667\">C176667</a></td><td>Water Repelling Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176668\">C176668</a></td><td>Wetting Excipient</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C176658\">C176658</a></td><td>pH Modifying Excipient</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" : "1.0.0-ballot",
"name" : "PqcmcExcipientFunctionTerminology",
"title" : "Excipient Function Terminology",
"status" : "active",
"experimental" : false,
"date" : "2024-04-08T17:51:06+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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"concept" : [
{
"code" : "C176637",
"display" : "Absorption Modifying Excipient"
},
{
"code" : "C89528",
"display" : "Adhesive Device"
},
{
"code" : "C176642",
"display" : "Adsorbent"
},
{
"code" : "C176643",
"display" : "Air Displacement Agent"
},
{
"code" : "C275",
"display" : "Antioxidant"
},
{
"code" : "C42647",
"display" : "Binder Excipient"
},
{
"code" : "C70815",
"display" : "Buffer"
},
{
"code" : "C176644",
"display" : "Bulking Excipient"
},
{
"code" : "C176645",
"display" : "Carrier Excipient"
},
{
"code" : "C360",
"display" : "Chelating Agent"
},
{
"code" : "C42656",
"display" : "Color Excipient"
},
{
"code" : "C176646",
"display" : "Complexing Excipient"
},
{
"code" : "C53306",
"display" : "Cryoprotective Agent"
},
{
"code" : "C176647",
"display" : "Denaturant"
},
{
"code" : "C42648",
"display" : "Disintegrant Excipient"
},
{
"code" : "C42662",
"display" : "Dispersing Excipient"
},
{
"code" : "C927",
"display" : "Drug Vehicle"
},
{
"code" : "C176638",
"display" : "Effervescent Excipient"
},
{
"code" : "C176632",
"display" : "Emollient Excipient"
},
{
"code" : "C73477",
"display" : "Emulsifying Excipient"
},
{
"code" : "C176633",
"display" : "Emulsion Stabilizing Excipient"
},
{
"code" : "C42650",
"display" : "Filler Excipient"
},
{
"code" : "C176648",
"display" : "Film Coating Excipient"
},
{
"code" : "C176634",
"display" : "Foam Stabilizing Excipient"
},
{
"code" : "C176649",
"display" : "Free Radical Scavenging Excipient"
},
{
"code" : "C176650",
"display" : "Gelling Excipient"
},
{
"code" : "C42654",
"display" : "Glidant Excipient"
},
{
"code" : "C176651",
"display" : "Humectant Excipient"
},
{
"code" : "C42653",
"display" : "Lubricant Excipient"
},
{
"code" : "C176652",
"display" : "Lyophilization Excipient"
},
{
"code" : "C176653",
"display" : "Matrix Forming Excipient"
},
{
"code" : "C176654",
"display" : "Microencapsulating Excipient"
},
{
"code" : "C176655",
"display" : "Ointment Base"
},
{
"code" : "C176656",
"display" : "Opacifying Excipient"
},
{
"code" : "C176660",
"display" : "Ophthalmic Polymer"
},
{
"code" : "C176635",
"display" : "Organoleptic Excipient"
},
{
"code" : "C176657",
"display" : "Osmotic Excipient"
},
{
"code" : "C55826",
"display" : "Plasticizer"
},
{
"code" : "C176659",
"display" : "Polishing Excipient"
},
{
"code" : "C42659",
"display" : "Preservative Excipient"
},
{
"code" : "C42657",
"display" : "Printing Ink Excipient"
},
{
"code" : "C176661",
"display" : "Propellant"
},
{
"code" : "C176639",
"display" : "Reducing Excipient"
},
{
"code" : "C176662",
"display" : "Release Modifying Excipient"
},
{
"code" : "C176640",
"display" : "Solubilizing Excipient"
},
{
"code" : "C45790",
"display" : "Solvent"
},
{
"code" : "C176636",
"display" : "Stabilizing Excipient"
},
{
"code" : "C176663",
"display" : "Suppository Base"
},
{
"code" : "C42739",
"display" : "Surfactant Excipient"
},
{
"code" : "C42660",
"display" : "Suspending Excipient"
},
{
"code" : "C176641",
"display" : "Tonicity Excipient"
},
{
"code" : "C176664",
"display" : "Transdermal Delivery Excipient"
},
{
"code" : "C176665",
"display" : "Transfer Ligand Excipient"
},
{
"code" : "C176666",
"display" : "Viscosity Modifying Excipient"
},
{
"code" : "C176667",
"display" : "Water Repelling Excipient"
},
{
"code" : "C176668",
"display" : "Wetting Excipient"
},
{
"code" : "C176658",
"display" : "pH Modifying Excipient"
}
]
}
]
}
}
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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