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 - TTL Representation

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

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    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
    @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
    @prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

    # - resource -------------------------------------------------------------------

     a fhir:ValueSet ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "pqcmc-excipient-function-terminology"] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir: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><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>"^^rdf:XMLLiteral
      ] ; #
      fhir:extension ( [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:code ;
    fhir:v "brr"     ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:integer ;
    fhir:v 2 ;
          ( fhir:extension [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:canonical ;
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda>         ]       ] )     ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:code ;
    fhir:v "trial-use" ;
          ( fhir:extension [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:canonical ;
    fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda>         ]       ] )     ]
      ] ) ; #
      fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology"^^xsd:anyURI] ; #
      fhir:identifier ( [
    fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.36.48.11" ]
      ] ) ; #
      fhir:version [ fhir:v "2.0.0"] ; #
      fhir:name [ fhir:v "PqcmcExcipientFunctionTerminology"] ; #
      fhir:title [ fhir:v "Excipient Function Terminology"] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:experimental [ fhir:v false] ; #
      fhir:date [ fhir:v "2025-07-03T13:07:08+00:00"^^xsd:dateTime] ; #
      fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; #
      fhir:contact ( [
    fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
        ( fhir:telecom [
    fhir:system [ fhir:v "url" ] ;
    fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]     ] [
    fhir:system [ fhir:v "email" ] ;
    fhir:value [ fhir:v "brr@lists.HL7.org" ]     ] )
      ] ) ; #
      fhir:description [ fhir:v "Terminology used to qualify the information pertaining to excipient functions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."] ; #
      fhir:jurisdiction ( [
        ( fhir:coding [
    fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "US" ] ;
    fhir:display [ fhir:v "United States of America" ]     ] )
      ] ) ; #
      fhir:compose [
        ( fhir:include [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
          ( fhir:concept [
    fhir:code [ fhir:v "C176637" ] ;
    fhir:display [ fhir:v "Absorption modifier" ]       ] [
    fhir:code [ fhir:v "C89528" ] ;
    fhir:display [ fhir:v "Adhesive" ]       ] [
    fhir:code [ fhir:v "C176642" ] ;
    fhir:display [ fhir:v "Adsorbent" ]       ] [
    fhir:code [ fhir:v "C176643" ] ;
    fhir:display [ fhir:v "Air displacement" ]       ] [
    fhir:code [ fhir:v "C275" ] ;
    fhir:display [ fhir:v "Antioxidant" ]       ] [
    fhir:code [ fhir:v "C42647" ] ;
    fhir:display [ fhir:v "Binder" ]       ] [
    fhir:code [ fhir:v "C70815" ] ;
    fhir:display [ fhir:v "Buffering agent" ]       ] [
    fhir:code [ fhir:v "C176644" ] ;
    fhir:display [ fhir:v "Bulking agent" ]       ] [
    fhir:code [ fhir:v "C176645" ] ;
    fhir:display [ fhir:v "Carrier" ]       ] [
    fhir:code [ fhir:v "C360" ] ;
    fhir:display [ fhir:v "Chelating agent" ]       ] [
    fhir:code [ fhir:v "C42656" ] ;
    fhir:display [ fhir:v "Coloring agent" ]       ] [
    fhir:code [ fhir:v "C176646" ] ;
    fhir:display [ fhir:v "Complexing agent" ]       ] [
    fhir:code [ fhir:v "C53306" ] ;
    fhir:display [ fhir:v "Cryoprotectant" ]       ] [
    fhir:code [ fhir:v "C176647" ] ;
    fhir:display [ fhir:v "Denaturant" ]       ] [
    fhir:code [ fhir:v "C42648" ] ;
    fhir:display [ fhir:v "Disintegrant" ]       ] [
    fhir:code [ fhir:v "C42662" ] ;
    fhir:display [ fhir:v "Dispersing agent" ]       ] [
    fhir:code [ fhir:v "C927" ] ;
    fhir:display [ fhir:v "Vehicle" ]       ] [
    fhir:code [ fhir:v "C176638" ] ;
    fhir:display [ fhir:v "Effervescent agent" ]       ] [
    fhir:code [ fhir:v "C176632" ] ;
    fhir:display [ fhir:v "Emollient" ]       ] [
    fhir:code [ fhir:v "C73477" ] ;
    fhir:display [ fhir:v "Emulsifying Excipient" ]       ] [
    fhir:code [ fhir:v "C176633" ] ;
    fhir:display [ fhir:v "Emulsion stabilizing agent" ]       ] [
    fhir:code [ fhir:v "C42650" ] ;
    fhir:display [ fhir:v "Filler" ]       ] [
    fhir:code [ fhir:v "C176648" ] ;
    fhir:display [ fhir:v "Film coating agent" ]       ] [
    fhir:code [ fhir:v "C176634" ] ;
    fhir:display [ fhir:v "Foam stabilizing agent" ]       ] [
    fhir:code [ fhir:v "C176649" ] ;
    fhir:display [ fhir:v "Free radical scavenger" ]       ] [
    fhir:code [ fhir:v "C176650" ] ;
    fhir:display [ fhir:v "Gelling agent" ]       ] [
    fhir:code [ fhir:v "C42654" ] ;
    fhir:display [ fhir:v "Anticaking agent" ]       ] [
    fhir:code [ fhir:v "C176651" ] ;
    fhir:display [ fhir:v "Humectant" ]       ] [
    fhir:code [ fhir:v "C42653" ] ;
    fhir:display [ fhir:v "Lubricant" ]       ] [
    fhir:code [ fhir:v "C176652" ] ;
    fhir:display [ fhir:v "Lyophilization aid" ]       ] [
    fhir:code [ fhir:v "C176653" ] ;
    fhir:display [ fhir:v "Matrix-forming agent" ]       ] [
    fhir:code [ fhir:v "C176654" ] ;
    fhir:display [ fhir:v "Microencapsulating agent" ]       ] [
    fhir:code [ fhir:v "C176655" ] ;
    fhir:display [ fhir:v "Ointment base" ]       ] [
    fhir:code [ fhir:v "C176656" ] ;
    fhir:display [ fhir:v "Opacifier" ]       ] [
    fhir:code [ fhir:v "C176660" ] ;
    fhir:display [ fhir:v "Polymers for ophthalmic use" ]       ] [
    fhir:code [ fhir:v "C176635" ] ;
    fhir:display [ fhir:v "Organoleptic agent" ]       ] [
    fhir:code [ fhir:v "C176657" ] ;
    fhir:display [ fhir:v "Osmotic agent" ]       ] [
    fhir:code [ fhir:v "C55826" ] ;
    fhir:display [ fhir:v "Plasticizer" ]       ] [
    fhir:code [ fhir:v "C176659" ] ;
    fhir:display [ fhir:v "Polishing agent" ]       ] [
    fhir:code [ fhir:v "C42659" ] ;
    fhir:display [ fhir:v "Preservative" ]       ] [
    fhir:code [ fhir:v "C42657" ] ;
    fhir:display [ fhir:v "Ink" ]       ] [
    fhir:code [ fhir:v "C176661" ] ;
    fhir:display [ fhir:v "Propellant" ]       ] [
    fhir:code [ fhir:v "C176639" ] ;
    fhir:display [ fhir:v "Reducing agent" ]       ] [
    fhir:code [ fhir:v "C176662" ] ;
    fhir:display [ fhir:v "Release modifying agent" ]       ] [
    fhir:code [ fhir:v "C176640" ] ;
    fhir:display [ fhir:v "Solubilizing agent" ]       ] [
    fhir:code [ fhir:v "C45790" ] ;
    fhir:display [ fhir:v "Solvent" ]       ] [
    fhir:code [ fhir:v "C176636" ] ;
    fhir:display [ fhir:v "Stabilizer" ]       ] [
    fhir:code [ fhir:v "C176663" ] ;
    fhir:display [ fhir:v "Suppository base" ]       ] [
    fhir:code [ fhir:v "C42739" ] ;
    fhir:display [ fhir:v "Surfactant" ]       ] [
    fhir:code [ fhir:v "C42660" ] ;
    fhir:display [ fhir:v "Suspending agent" ]       ] [
    fhir:code [ fhir:v "C176641" ] ;
    fhir:display [ fhir:v "Tonicity agent" ]       ] [
    fhir:code [ fhir:v "C176664" ] ;
    fhir:display [ fhir:v "Transdermal delivery component" ]       ] [
    fhir:code [ fhir:v "C176665" ] ;
    fhir:display [ fhir:v "Transfer ligand" ]       ] [
    fhir:code [ fhir:v "C176666" ] ;
    fhir:display [ fhir:v "Viscosity modifier" ]       ] [
    fhir:code [ fhir:v "C176667" ] ;
    fhir:display [ fhir:v "Water-repelling agent" ]       ] [
    fhir:code [ fhir:v "C176668" ] ;
    fhir:display [ fhir:v "Wetting agent" ]       ] [
    fhir:code [ fhir:v "C176658" ] ;
    fhir:display [ fhir:v "pH modifier" ]       ] )     ] )
      ] . #