Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions

: Excipient Function Terminology - XML Representation

Draft as of 2024-03-04

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<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"/>
  <version value="0.1.20"/>
  <name value="PqcmcExcipientFunctionTerminology"/>
  <title value="Excipient Function Terminology"/>
  <status value="draft"/>
  <experimental value="true"/>
  <date value="2024-03-04T02:24:01+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>