Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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: Test Category Terminology - TTL Representation

Active as of 2024-12-12

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@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-test-category-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-test-category-terminology</b></p><a name=\"pqcmc-test-category-terminology\"> </a><a name=\"hcpqcmc-test-category-terminology\"> </a><a name=\"pqcmc-test-category-terminology-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.1.0/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>C60819</td><td>Assay</td></tr><tr><td>C204845</td><td>Active Ingredient Content</td></tr><tr><td>C205001</td><td>Adventitious Agents (Safety)</td></tr><tr><td>C81183</td><td>Amino Acid Content</td></tr><tr><td>C205003</td><td>Bioburden</td></tr><tr><td>C205007</td><td>Counterion Content</td></tr><tr><td>C205015</td><td>Excipient</td></tr><tr><td>C205018</td><td>Host Cell DNA</td></tr><tr><td>C205020</td><td>In Vitro or In Vivo Test for Viral Contaminants</td></tr><tr><td>C205028</td><td>Percent Conjugate</td></tr><tr><td>C62352</td><td>Purity</td></tr><tr><td>C171277</td><td>Nucleic Acid Content</td></tr><tr><td>C205038</td><td>Solvate Content</td></tr><tr><td>C64858</td><td>Total Protein</td></tr><tr><td>C205006</td><td>Cell and Gene Therapy Product Characterization Assay</td></tr><tr><td>C134249</td><td>Container Closure Integrity</td></tr><tr><td>C134250</td><td>Uniformity</td></tr><tr><td>C205004</td><td>Blend Uniformity</td></tr><tr><td>C205019</td><td>IPC Content Uniformity</td></tr><tr><td>C134115</td><td>Uniformity of Dosage Unit</td></tr><tr><td>C205050</td><td>Uniformity in Containers</td></tr><tr><td>C133961</td><td>Deliverable Volume/Fill Volume</td></tr><tr><td>C205026</td><td>Organoleptic</td></tr><tr><td>C138990</td><td>Description/Appearance</td></tr><tr><td>C139027</td><td>Odor</td></tr><tr><td>C134262</td><td>Color of Solution</td></tr><tr><td>C134261</td><td>Clarity of Solution</td></tr><tr><td>C138993</td><td>Identification</td></tr><tr><td>C134252</td><td>Disintegration</td></tr><tr><td>C134253</td><td>Dissolution</td></tr><tr><td>C205012</td><td>Droplet Size</td></tr><tr><td>C193381</td><td>Foreign and Particulate Matter</td></tr><tr><td>C205024</td><td>Metal Detection</td></tr><tr><td>C134255</td><td>Loss on Drying</td></tr><tr><td>C134256</td><td>Microbial Limits</td></tr><tr><td>C205027</td><td>Osmolality/Osmolarity</td></tr><tr><td>C134257</td><td>Particle Size Distribution</td></tr><tr><td>C134260</td><td>Bulk Density</td></tr><tr><td>C134263</td><td>Conductivity</td></tr><tr><td>C133974</td><td>Crystallinity</td></tr><tr><td>C133975</td><td>Friability</td></tr><tr><td>C134264</td><td>Hardness</td></tr><tr><td>C63394</td><td>Melting Point</td></tr><tr><td>C103201</td><td>Optical Rotation</td></tr><tr><td>C205029</td><td>pH</td></tr><tr><td>C60821</td><td>Solubility</td></tr><tr><td>C64832</td><td>Specific Gravity</td></tr><tr><td>C25483</td><td>Material Properties/Measurements</td></tr><tr><td>C205022</td><td>Individual Weight</td></tr><tr><td>C205017</td><td>Group Weight</td></tr><tr><td>C205209</td><td>Average Weight</td></tr><tr><td>C205053</td><td>Weight Variation</td></tr><tr><td>C205021</td><td>Individual Fill Weight</td></tr><tr><td>C205016</td><td>Group Fill Weight</td></tr><tr><td>C205206</td><td>Average Fill Weight</td></tr><tr><td>C205045</td><td>Target Group Weight Gain %</td></tr><tr><td>C205036</td><td>Shell Weight</td></tr><tr><td>C205011</td><td>Orifice Location</td></tr><tr><td>C205010</td><td>Orifice Diameter</td></tr><tr><td>C205009</td><td>Orifice Depth</td></tr><tr><td>C205037</td><td>Drilled Side (Single or Double)</td></tr><tr><td>C205025</td><td>Number of Orifices</td></tr><tr><td>C205034</td><td>Ribbon Thickness</td></tr><tr><td>C205033</td><td>Ribbon Density</td></tr><tr><td>C205035</td><td>Seam Thickness</td></tr><tr><td>C205005</td><td>Lock Length</td></tr><tr><td>C205044</td><td>Tablet/Capsule Length</td></tr><tr><td>C205043</td><td>Tablet/Capsule Diameter</td></tr><tr><td>C205042</td><td>Tablet Thickness</td></tr><tr><td>C134266</td><td>Tap Density</td></tr><tr><td>C205049</td><td>Transdermal Properties</td></tr><tr><td>C133979</td><td>Viscosity/Rheological Properties</td></tr><tr><td>C134267</td><td>Plume Geometry</td></tr><tr><td>C134269</td><td>Polymorphism</td></tr><tr><td>C205030</td><td>Porosity</td></tr><tr><td>C134270</td><td>Potency</td></tr><tr><td>C133983</td><td>Pyrogenicity/Endotoxin</td></tr><tr><td>C134272</td><td>Reconstitution Time</td></tr><tr><td>C133985</td><td>Redispersibility</td></tr><tr><td>C205032</td><td>Refractive Index</td></tr><tr><td>C134276</td><td>Residue on Ignition</td></tr><tr><td>C134277</td><td>Spray Pattern</td></tr><tr><td>C134278</td><td>Sterility</td></tr><tr><td>C134113</td><td>Syringe Functionality</td></tr><tr><td>C134114</td><td>Total Organic Carbon</td></tr><tr><td>C200004</td><td>Cytotoxicity</td></tr><tr><td>C205023</td><td>Mechanical Integrity</td></tr><tr><td>C205041</td><td>Surface Area</td></tr><tr><td>C18951</td><td>Post-translational Modifications</td></tr><tr><td>C16643</td><td>Glycosylation</td></tr><tr><td>C205054</td><td>Thrombin Peptide Map</td></tr><tr><td>C205031</td><td>Sialylation</td></tr><tr><td>C205002</td><td>Amidation</td></tr><tr><td>C205008</td><td>Deamidation</td></tr><tr><td>C205000</td><td>Functional Assays</td></tr><tr><td>C205013</td><td>Elemental Analysis</td></tr><tr><td>C74723</td><td>Turbidity</td></tr><tr><td>C204971</td><td>Impurity</td></tr><tr><td>C205039</td><td>Specified Identified Impurity</td></tr><tr><td>C205040</td><td>Specified Unidentified Impurity</td></tr><tr><td>C205052</td><td>Unspecified Impurity</td></tr><tr><td>C205047</td><td>Total Impurities</td></tr><tr><td>C205048</td><td>Total Unknown Impurities</td></tr><tr><td>C205051</td><td>Identified Impurity under IT, Monitored as Unspecified</td></tr><tr><td>C205014</td><td>Elemental Impurity</td></tr><tr><td>C204890</td><td>Impurity Chemical</td></tr><tr><td>C134254</td><td>Impurities/Degradation Products/Related Substances</td></tr><tr><td>C134002</td><td>Residual Solvent</td></tr></table></li></ul></div>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/valueset-supplement"^^xsd:anyURI ] ;
fhir:value [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-hierarchy-supplement"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-hierarchy-supplement>     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [ fhir:v "brr" ]
  ] ) ; # 
  fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology"^^xsd:anyURI] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.36.48.28" ]
  ] ) ; # 
  fhir:version [ fhir:v "2.0.0-ballot"] ; # 
  fhir:name [ fhir:v "PqcmcTestCategoryTerminology"] ; # 
  fhir:title [ fhir:v "Test Category Terminology"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # 
  fhir:date [ fhir:v "2024-12-12T19:00:52+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 test categories 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 "C60819" ] ;
fhir:display [ fhir:v "Assay" ]       ] [
fhir:code [ fhir:v "C204845" ] ;
fhir:display [ fhir:v "Active Ingredient Content" ]       ] [
fhir:code [ fhir:v "C205001" ] ;
fhir:display [ fhir:v "Adventitious Agents (Safety)" ]       ] [
fhir:code [ fhir:v "C81183" ] ;
fhir:display [ fhir:v "Amino Acid Content" ]       ] [
fhir:code [ fhir:v "C205003" ] ;
fhir:display [ fhir:v "Bioburden" ]       ] [
fhir:code [ fhir:v "C205007" ] ;
fhir:display [ fhir:v "Counterion Content" ]       ] [
fhir:code [ fhir:v "C205015" ] ;
fhir:display [ fhir:v "Excipient" ]       ] [
fhir:code [ fhir:v "C205018" ] ;
fhir:display [ fhir:v "Host Cell DNA" ]       ] [
fhir:code [ fhir:v "C205020" ] ;
fhir:display [ fhir:v "In Vitro or In Vivo Test for Viral Contaminants" ]       ] [
fhir:code [ fhir:v "C205028" ] ;
fhir:display [ fhir:v "Percent Conjugate" ]       ] [
fhir:code [ fhir:v "C62352" ] ;
fhir:display [ fhir:v "Purity" ]       ] [
fhir:code [ fhir:v "C171277" ] ;
fhir:display [ fhir:v "Nucleic Acid Content" ]       ] [
fhir:code [ fhir:v "C205038" ] ;
fhir:display [ fhir:v "Solvate Content" ]       ] [
fhir:code [ fhir:v "C64858" ] ;
fhir:display [ fhir:v "Total Protein" ]       ] [
fhir:code [ fhir:v "C205006" ] ;
fhir:display [ fhir:v "Cell and Gene Therapy Product Characterization Assay" ]       ] [
fhir:code [ fhir:v "C134249" ] ;
fhir:display [ fhir:v "Container Closure Integrity" ]       ] [
fhir:code [ fhir:v "C134250" ] ;
fhir:display [ fhir:v "Uniformity" ]       ] [
fhir:code [ fhir:v "C205004" ] ;
fhir:display [ fhir:v "Blend Uniformity" ]       ] [
fhir:code [ fhir:v "C205019" ] ;
fhir:display [ fhir:v "IPC Content Uniformity" ]       ] [
fhir:code [ fhir:v "C134115" ] ;
fhir:display [ fhir:v "Uniformity of Dosage Unit" ]       ] [
fhir:code [ fhir:v "C205050" ] ;
fhir:display [ fhir:v "Uniformity in Containers" ]       ] [
fhir:code [ fhir:v "C133961" ] ;
fhir:display [ fhir:v "Deliverable Volume/Fill Volume" ]       ] [
fhir:code [ fhir:v "C205026" ] ;
fhir:display [ fhir:v "Organoleptic" ]       ] [
fhir:code [ fhir:v "C138990" ] ;
fhir:display [ fhir:v "Description/Appearance" ]       ] [
fhir:code [ fhir:v "C139027" ] ;
fhir:display [ fhir:v "Odor" ]       ] [
fhir:code [ fhir:v "C134262" ] ;
fhir:display [ fhir:v "Color of Solution" ]       ] [
fhir:code [ fhir:v "C134261" ] ;
fhir:display [ fhir:v "Clarity of Solution" ]       ] [
fhir:code [ fhir:v "C138993" ] ;
fhir:display [ fhir:v "Identification" ]       ] [
fhir:code [ fhir:v "C134252" ] ;
fhir:display [ fhir:v "Disintegration" ]       ] [
fhir:code [ fhir:v "C134253" ] ;
fhir:display [ fhir:v "Dissolution" ]       ] [
fhir:code [ fhir:v "C205012" ] ;
fhir:display [ fhir:v "Droplet Size" ]       ] [
fhir:code [ fhir:v "C193381" ] ;
fhir:display [ fhir:v "Foreign and Particulate Matter" ]       ] [
fhir:code [ fhir:v "C205024" ] ;
fhir:display [ fhir:v "Metal Detection" ]       ] [
fhir:code [ fhir:v "C134255" ] ;
fhir:display [ fhir:v "Loss on Drying" ]       ] [
fhir:code [ fhir:v "C134256" ] ;
fhir:display [ fhir:v "Microbial Limits" ]       ] [
fhir:code [ fhir:v "C205027" ] ;
fhir:display [ fhir:v "Osmolality/Osmolarity" ]       ] [
fhir:code [ fhir:v "C134257" ] ;
fhir:display [ fhir:v "Particle Size Distribution" ]       ] [
fhir:code [ fhir:v "C134260" ] ;
fhir:display [ fhir:v "Bulk Density" ]       ] [
fhir:code [ fhir:v "C134263" ] ;
fhir:display [ fhir:v "Conductivity" ]       ] [
fhir:code [ fhir:v "C133974" ] ;
fhir:display [ fhir:v "Crystallinity" ]       ] [
fhir:code [ fhir:v "C133975" ] ;
fhir:display [ fhir:v "Friability" ]       ] [
fhir:code [ fhir:v "C134264" ] ;
fhir:display [ fhir:v "Hardness" ]       ] [
fhir:code [ fhir:v "C63394" ] ;
fhir:display [ fhir:v "Melting Point" ]       ] [
fhir:code [ fhir:v "C103201" ] ;
fhir:display [ fhir:v "Optical Rotation" ]       ] [
fhir:code [ fhir:v "C205029" ] ;
fhir:display [ fhir:v "pH" ]       ] [
fhir:code [ fhir:v "C60821" ] ;
fhir:display [ fhir:v "Solubility" ]       ] [
fhir:code [ fhir:v "C64832" ] ;
fhir:display [ fhir:v "Specific Gravity" ]       ] [
fhir:code [ fhir:v "C25483" ] ;
fhir:display [ fhir:v "Material Properties/Measurements" ]       ] [
fhir:code [ fhir:v "C205022" ] ;
fhir:display [ fhir:v "Individual Weight" ]       ] [
fhir:code [ fhir:v "C205017" ] ;
fhir:display [ fhir:v "Group Weight" ]       ] [
fhir:code [ fhir:v "C205209" ] ;
fhir:display [ fhir:v "Average Weight" ]       ] [
fhir:code [ fhir:v "C205053" ] ;
fhir:display [ fhir:v "Weight Variation" ]       ] [
fhir:code [ fhir:v "C205021" ] ;
fhir:display [ fhir:v "Individual Fill Weight" ]       ] [
fhir:code [ fhir:v "C205016" ] ;
fhir:display [ fhir:v "Group Fill Weight" ]       ] [
fhir:code [ fhir:v "C205206" ] ;
fhir:display [ fhir:v "Average Fill Weight" ]       ] [
fhir:code [ fhir:v "C205045" ] ;
fhir:display [ fhir:v "Target Group Weight Gain %" ]       ] [
fhir:code [ fhir:v "C205036" ] ;
fhir:display [ fhir:v "Shell Weight" ]       ] [
fhir:code [ fhir:v "C205011" ] ;
fhir:display [ fhir:v "Orifice Location" ]       ] [
fhir:code [ fhir:v "C205010" ] ;
fhir:display [ fhir:v "Orifice Diameter" ]       ] [
fhir:code [ fhir:v "C205009" ] ;
fhir:display [ fhir:v "Orifice Depth" ]       ] [
fhir:code [ fhir:v "C205037" ] ;
fhir:display [ fhir:v "Drilled Side (Single or Double)" ]       ] [
fhir:code [ fhir:v "C205025" ] ;
fhir:display [ fhir:v "Number of Orifices" ]       ] [
fhir:code [ fhir:v "C205034" ] ;
fhir:display [ fhir:v "Ribbon Thickness" ]       ] [
fhir:code [ fhir:v "C205033" ] ;
fhir:display [ fhir:v "Ribbon Density" ]       ] [
fhir:code [ fhir:v "C205035" ] ;
fhir:display [ fhir:v "Seam Thickness" ]       ] [
fhir:code [ fhir:v "C205005" ] ;
fhir:display [ fhir:v "Lock Length" ]       ] [
fhir:code [ fhir:v "C205044" ] ;
fhir:display [ fhir:v "Tablet/Capsule Length" ]       ] [
fhir:code [ fhir:v "C205043" ] ;
fhir:display [ fhir:v "Tablet/Capsule Diameter" ]       ] [
fhir:code [ fhir:v "C205042" ] ;
fhir:display [ fhir:v "Tablet Thickness" ]       ] [
fhir:code [ fhir:v "C134266" ] ;
fhir:display [ fhir:v "Tap Density" ]       ] [
fhir:code [ fhir:v "C205049" ] ;
fhir:display [ fhir:v "Transdermal Properties" ]       ] [
fhir:code [ fhir:v "C133979" ] ;
fhir:display [ fhir:v "Viscosity/Rheological Properties" ]       ] [
fhir:code [ fhir:v "C134267" ] ;
fhir:display [ fhir:v "Plume Geometry" ]       ] [
fhir:code [ fhir:v "C134269" ] ;
fhir:display [ fhir:v "Polymorphism" ]       ] [
fhir:code [ fhir:v "C205030" ] ;
fhir:display [ fhir:v "Porosity" ]       ] [
fhir:code [ fhir:v "C134270" ] ;
fhir:display [ fhir:v "Potency" ]       ] [
fhir:code [ fhir:v "C133983" ] ;
fhir:display [ fhir:v "Pyrogenicity/Endotoxin" ]       ] [
fhir:code [ fhir:v "C134272" ] ;
fhir:display [ fhir:v "Reconstitution Time" ]       ] [
fhir:code [ fhir:v "C133985" ] ;
fhir:display [ fhir:v "Redispersibility" ]       ] [
fhir:code [ fhir:v "C205032" ] ;
fhir:display [ fhir:v "Refractive Index" ]       ] [
fhir:code [ fhir:v "C134276" ] ;
fhir:display [ fhir:v "Residue on Ignition" ]       ] [
fhir:code [ fhir:v "C134277" ] ;
fhir:display [ fhir:v "Spray Pattern" ]       ] [
fhir:code [ fhir:v "C134278" ] ;
fhir:display [ fhir:v "Sterility" ]       ] [
fhir:code [ fhir:v "C134113" ] ;
fhir:display [ fhir:v "Syringe Functionality" ]       ] [
fhir:code [ fhir:v "C134114" ] ;
fhir:display [ fhir:v "Total Organic Carbon" ]       ] [
fhir:code [ fhir:v "C200004" ] ;
fhir:display [ fhir:v "Cytotoxicity" ]       ] [
fhir:code [ fhir:v "C205023" ] ;
fhir:display [ fhir:v "Mechanical Integrity" ]       ] [
fhir:code [ fhir:v "C205041" ] ;
fhir:display [ fhir:v "Surface Area" ]       ] [
fhir:code [ fhir:v "C18951" ] ;
fhir:display [ fhir:v "Post-translational Modifications" ]       ] [
fhir:code [ fhir:v "C16643" ] ;
fhir:display [ fhir:v "Glycosylation" ]       ] [
fhir:code [ fhir:v "C205054" ] ;
fhir:display [ fhir:v "Thrombin Peptide Map" ]       ] [
fhir:code [ fhir:v "C205031" ] ;
fhir:display [ fhir:v "Sialylation" ]       ] [
fhir:code [ fhir:v "C205002" ] ;
fhir:display [ fhir:v "Amidation" ]       ] [
fhir:code [ fhir:v "C205008" ] ;
fhir:display [ fhir:v "Deamidation" ]       ] [
fhir:code [ fhir:v "C205000" ] ;
fhir:display [ fhir:v "Functional Assays" ]       ] [
fhir:code [ fhir:v "C205013" ] ;
fhir:display [ fhir:v "Elemental Analysis" ]       ] [
fhir:code [ fhir:v "C74723" ] ;
fhir:display [ fhir:v "Turbidity" ]       ] [
fhir:code [ fhir:v "C204971" ] ;
fhir:display [ fhir:v "Impurity" ]       ] [
fhir:code [ fhir:v "C205039" ] ;
fhir:display [ fhir:v "Specified Identified Impurity" ]       ] [
fhir:code [ fhir:v "C205040" ] ;
fhir:display [ fhir:v "Specified Unidentified Impurity" ]       ] [
fhir:code [ fhir:v "C205052" ] ;
fhir:display [ fhir:v "Unspecified Impurity" ]       ] [
fhir:code [ fhir:v "C205047" ] ;
fhir:display [ fhir:v "Total Impurities" ]       ] [
fhir:code [ fhir:v "C205048" ] ;
fhir:display [ fhir:v "Total Unknown Impurities" ]       ] [
fhir:code [ fhir:v "C205051" ] ;
fhir:display [ fhir:v "Identified Impurity under IT, Monitored as Unspecified" ]       ] [
fhir:code [ fhir:v "C205014" ] ;
fhir:display [ fhir:v "Elemental Impurity" ]       ] [
fhir:code [ fhir:v "C204890" ] ;
fhir:display [ fhir:v "Impurity Chemical" ]       ] [
fhir:code [ fhir:v "C134254" ] ;
fhir:display [ fhir:v "Impurities/Degradation Products/Related Substances" ]       ] [
fhir:code [ fhir:v "C134002" ] ;
fhir:display [ fhir:v "Residual Solvent" ]       ] )     ] )
  ] . #