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 |
<ValueSet xmlns="http://hl7.org/fhir">
<id value="pqcmc-excipient-function-terminology"/>
<text>
<status value="generated"/>
<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>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.11"/>
</identifier>
<version value="1.0.0-ballot"/>
<name value="PqcmcExcipientFunctionTerminology"/>
<title value="Excipient Function Terminology"/>
<status value="active"/>
<experimental value="false"/>
<date value="2024-04-08T17:51:06+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
<telecom>
<system value="email"/>
<value value="brr@lists.HL7.org"/>
</telecom>
</contact>
<description
value="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 value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<compose>
<include>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<concept>
<code value="C176637"/>
<display value="Absorption Modifying Excipient"/>
</concept>
<concept>
<code value="C89528"/>
<display value="Adhesive Device"/>
</concept>
<concept>
<code value="C176642"/>
<display value="Adsorbent"/>
</concept>
<concept>
<code value="C176643"/>
<display value="Air Displacement Agent"/>
</concept>
<concept>
<code value="C275"/>
<display value="Antioxidant"/>
</concept>
<concept>
<code value="C42647"/>
<display value="Binder Excipient"/>
</concept>
<concept>
<code value="C70815"/>
<display value="Buffer"/>
</concept>
<concept>
<code value="C176644"/>
<display value="Bulking Excipient"/>
</concept>
<concept>
<code value="C176645"/>
<display value="Carrier Excipient"/>
</concept>
<concept>
<code value="C360"/>
<display value="Chelating Agent"/>
</concept>
<concept>
<code value="C42656"/>
<display value="Color Excipient"/>
</concept>
<concept>
<code value="C176646"/>
<display value="Complexing Excipient"/>
</concept>
<concept>
<code value="C53306"/>
<display value="Cryoprotective Agent"/>
</concept>
<concept>
<code value="C176647"/>
<display value="Denaturant"/>
</concept>
<concept>
<code value="C42648"/>
<display value="Disintegrant Excipient"/>
</concept>
<concept>
<code value="C42662"/>
<display value="Dispersing Excipient"/>
</concept>
<concept>
<code value="C927"/>
<display value="Drug Vehicle"/>
</concept>
<concept>
<code value="C176638"/>
<display value="Effervescent Excipient"/>
</concept>
<concept>
<code value="C176632"/>
<display value="Emollient Excipient"/>
</concept>
<concept>
<code value="C73477"/>
<display value="Emulsifying Excipient"/>
</concept>
<concept>
<code value="C176633"/>
<display value="Emulsion Stabilizing Excipient"/>
</concept>
<concept>
<code value="C42650"/>
<display value="Filler Excipient"/>
</concept>
<concept>
<code value="C176648"/>
<display value="Film Coating Excipient"/>
</concept>
<concept>
<code value="C176634"/>
<display value="Foam Stabilizing Excipient"/>
</concept>
<concept>
<code value="C176649"/>
<display value="Free Radical Scavenging Excipient"/>
</concept>
<concept>
<code value="C176650"/>
<display value="Gelling Excipient"/>
</concept>
<concept>
<code value="C42654"/>
<display value="Glidant Excipient"/>
</concept>
<concept>
<code value="C176651"/>
<display value="Humectant Excipient"/>
</concept>
<concept>
<code value="C42653"/>
<display value="Lubricant Excipient"/>
</concept>
<concept>
<code value="C176652"/>
<display value="Lyophilization Excipient"/>
</concept>
<concept>
<code value="C176653"/>
<display value="Matrix Forming Excipient"/>
</concept>
<concept>
<code value="C176654"/>
<display value="Microencapsulating Excipient"/>
</concept>
<concept>
<code value="C176655"/>
<display value="Ointment Base"/>
</concept>
<concept>
<code value="C176656"/>
<display value="Opacifying Excipient"/>
</concept>
<concept>
<code value="C176660"/>
<display value="Ophthalmic Polymer"/>
</concept>
<concept>
<code value="C176635"/>
<display value="Organoleptic Excipient"/>
</concept>
<concept>
<code value="C176657"/>
<display value="Osmotic Excipient"/>
</concept>
<concept>
<code value="C55826"/>
<display value="Plasticizer"/>
</concept>
<concept>
<code value="C176659"/>
<display value="Polishing Excipient"/>
</concept>
<concept>
<code value="C42659"/>
<display value="Preservative Excipient"/>
</concept>
<concept>
<code value="C42657"/>
<display value="Printing Ink Excipient"/>
</concept>
<concept>
<code value="C176661"/>
<display value="Propellant"/>
</concept>
<concept>
<code value="C176639"/>
<display value="Reducing Excipient"/>
</concept>
<concept>
<code value="C176662"/>
<display value="Release Modifying Excipient"/>
</concept>
<concept>
<code value="C176640"/>
<display value="Solubilizing Excipient"/>
</concept>
<concept>
<code value="C45790"/>
<display value="Solvent"/>
</concept>
<concept>
<code value="C176636"/>
<display value="Stabilizing Excipient"/>
</concept>
<concept>
<code value="C176663"/>
<display value="Suppository Base"/>
</concept>
<concept>
<code value="C42739"/>
<display value="Surfactant Excipient"/>
</concept>
<concept>
<code value="C42660"/>
<display value="Suspending Excipient"/>
</concept>
<concept>
<code value="C176641"/>
<display value="Tonicity Excipient"/>
</concept>
<concept>
<code value="C176664"/>
<display value="Transdermal Delivery Excipient"/>
</concept>
<concept>
<code value="C176665"/>
<display value="Transfer Ligand Excipient"/>
</concept>
<concept>
<code value="C176666"/>
<display value="Viscosity Modifying Excipient"/>
</concept>
<concept>
<code value="C176667"/>
<display value="Water Repelling Excipient"/>
</concept>
<concept>
<code value="C176668"/>
<display value="Wetting Excipient"/>
</concept>
<concept>
<code value="C176658"/>
<display value="pH Modifying Excipient"/>
</concept>
</include>
</compose>
</ValueSet>
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
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change