Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 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

## : Excipient Function Terminology - XML Representation

Page standards status: Trial-use | Maturity Level: 2

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        <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><ul><li>Include these codes as defined in <a href="http://terminology.hl7.org/6.4.0/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>
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      <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="2.0.0"/>
      <name value="PqcmcExcipientFunctionTerminology"/>
      <title value="Excipient Function Terminology"/>
      <status value="active"/>
      <experimental value="false"/>
      <date value="2025-07-03T13:07:08+00:00"/>
      <publisher value="HL7 International / Biomedical Research and Regulation"/>
      <contact>
        <name value="HL7 International / Biomedical Research and Regulation"/>
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      <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"/>
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      <compose>
        <include>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <concept>
            <code value="C176637"/>
            <display value="Absorption modifier"/>
          </concept>
          <concept>
            <code value="C89528"/>
            <display value="Adhesive"/>
          </concept>
          <concept>
            <code value="C176642"/>
            <display value="Adsorbent"/>
          </concept>
          <concept>
            <code value="C176643"/>
            <display value="Air displacement"/>
          </concept>
          <concept>
            <code value="C275"/>
            <display value="Antioxidant"/>
          </concept>
          <concept>
            <code value="C42647"/>
            <display value="Binder"/>
          </concept>
          <concept>
            <code value="C70815"/>
            <display value="Buffering agent"/>
          </concept>
          <concept>
            <code value="C176644"/>
            <display value="Bulking agent"/>
          </concept>
          <concept>
            <code value="C176645"/>
            <display value="Carrier"/>
          </concept>
          <concept>
            <code value="C360"/>
            <display value="Chelating agent"/>
          </concept>
          <concept>
            <code value="C42656"/>
            <display value="Coloring agent"/>
          </concept>
          <concept>
            <code value="C176646"/>
            <display value="Complexing agent"/>
          </concept>
          <concept>
            <code value="C53306"/>
            <display value="Cryoprotectant"/>
          </concept>
          <concept>
            <code value="C176647"/>
            <display value="Denaturant"/>
          </concept>
          <concept>
            <code value="C42648"/>
            <display value="Disintegrant"/>
          </concept>
          <concept>
            <code value="C42662"/>
            <display value="Dispersing agent"/>
          </concept>
          <concept>
            <code value="C927"/>
            <display value="Vehicle"/>
          </concept>
          <concept>
            <code value="C176638"/>
            <display value="Effervescent agent"/>
          </concept>
          <concept>
            <code value="C176632"/>
            <display value="Emollient"/>
          </concept>
          <concept>
            <code value="C73477"/>
            <display value="Emulsifying Excipient"/>
          </concept>
          <concept>
            <code value="C176633"/>
            <display value="Emulsion stabilizing agent"/>
          </concept>
          <concept>
            <code value="C42650"/>
            <display value="Filler"/>
          </concept>
          <concept>
            <code value="C176648"/>
            <display value="Film coating agent"/>
          </concept>
          <concept>
            <code value="C176634"/>
            <display value="Foam stabilizing agent"/>
          </concept>
          <concept>
            <code value="C176649"/>
            <display value="Free radical scavenger"/>
          </concept>
          <concept>
            <code value="C176650"/>
            <display value="Gelling agent"/>
          </concept>
          <concept>
            <code value="C42654"/>
            <display value="Anticaking agent"/>
          </concept>
          <concept>
            <code value="C176651"/>
            <display value="Humectant"/>
          </concept>
          <concept>
            <code value="C42653"/>
            <display value="Lubricant"/>
          </concept>
          <concept>
            <code value="C176652"/>
            <display value="Lyophilization aid"/>
          </concept>
          <concept>
            <code value="C176653"/>
            <display value="Matrix-forming agent"/>
          </concept>
          <concept>
            <code value="C176654"/>
            <display value="Microencapsulating agent"/>
          </concept>
          <concept>
            <code value="C176655"/>
            <display value="Ointment base"/>
          </concept>
          <concept>
            <code value="C176656"/>
            <display value="Opacifier"/>
          </concept>
          <concept>
            <code value="C176660"/>
            <display value="Polymers for ophthalmic use"/>
          </concept>
          <concept>
            <code value="C176635"/>
            <display value="Organoleptic agent"/>
          </concept>
          <concept>
            <code value="C176657"/>
            <display value="Osmotic agent"/>
          </concept>
          <concept>
            <code value="C55826"/>
            <display value="Plasticizer"/>
          </concept>
          <concept>
            <code value="C176659"/>
            <display value="Polishing agent"/>
          </concept>
          <concept>
            <code value="C42659"/>
            <display value="Preservative"/>
          </concept>
          <concept>
            <code value="C42657"/>
            <display value="Ink"/>
          </concept>
          <concept>
            <code value="C176661"/>
            <display value="Propellant"/>
          </concept>
          <concept>
            <code value="C176639"/>
            <display value="Reducing agent"/>
          </concept>
          <concept>
            <code value="C176662"/>
            <display value="Release modifying agent"/>
          </concept>
          <concept>
            <code value="C176640"/>
            <display value="Solubilizing agent"/>
          </concept>
          <concept>
            <code value="C45790"/>
            <display value="Solvent"/>
          </concept>
          <concept>
            <code value="C176636"/>
            <display value="Stabilizer"/>
          </concept>
          <concept>
            <code value="C176663"/>
            <display value="Suppository base"/>
          </concept>
          <concept>
            <code value="C42739"/>
            <display value="Surfactant"/>
          </concept>
          <concept>
            <code value="C42660"/>
            <display value="Suspending agent"/>
          </concept>
          <concept>
            <code value="C176641"/>
            <display value="Tonicity agent"/>
          </concept>
          <concept>
            <code value="C176664"/>
            <display value="Transdermal delivery component"/>
          </concept>
          <concept>
            <code value="C176665"/>
            <display value="Transfer ligand"/>
          </concept>
          <concept>
            <code value="C176666"/>
            <display value="Viscosity modifier"/>
          </concept>
          <concept>
            <code value="C176667"/>
            <display value="Water-repelling agent"/>
          </concept>
          <concept>
            <code value="C176668"/>
            <display value="Wetting agent"/>
          </concept>
          <concept>
            <code value="C176658"/>
            <display value="pH modifier"/>
          </concept>
        </include>
      </compose>
    </ValueSet>