FHIR IG Statistics: ValueSet/pqcmc-test-category-terminology
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Resources that this resource uses
Narrative
Note: links and images are rebased to the (stated) source
This ValueSet requires the Code system Supplement PQ-CMC-FDA NCIt Hierarchy Supplement.
- Include these codes as defined in
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl| Code | Display |
| C60819 | Assay |
| C204845 | Active Ingredient Content |
| C205001 | Adventitious Agents (Safety) |
| C81183 | Amino Acid Content |
| C205003 | Bioburden |
| C205007 | Counterion Content |
| C205015 | Excipient |
| C205018 | Host Cell DNA |
| C205020 | In Vitro or In Vivo Test for Viral Contaminants |
| C205028 | Percent Conjugate |
| C62352 | Purity |
| C171277 | Nucleic Acid Content |
| C205038 | Solvate Content |
| C64858 | Total Protein |
| C205006 | Cell and Gene Therapy Product Characterization Assay |
| C134249 | Container Closure Integrity |
| C134250 | Uniformity |
| C205004 | Blend Uniformity |
| C205019 | IPC Content Uniformity |
| C134115 | Uniformity of Dosage Unit |
| C205050 | Uniformity in Containers |
| C133961 | Deliverable Volume/Fill Volume |
| C205026 | Organoleptic |
| C138990 | Description/Appearance |
| C139027 | Odor |
| C134262 | Color of Solution |
| C134261 | Clarity of Solution |
| C138993 | Identification |
| C134252 | Disintegration |
| C134253 | Dissolution |
| C205012 | Droplet Size |
| C193381 | Foreign and Particulate Matter |
| C205024 | Metal Detection |
| C134255 | Loss on Drying |
| C134256 | Microbial Limits |
| C205027 | Osmolality/Osmolarity |
| C134257 | Particle Size Distribution |
| C134260 | Bulk Density |
| C134263 | Conductivity |
| C133974 | Crystallinity |
| C133975 | Friability |
| C134264 | Hardness |
| C63394 | Melting Point |
| C103201 | Optical Rotation |
| C205029 | pH |
| C60821 | Solubility |
| C64832 | Specific Gravity |
| C25483 | Material Properties/Measurements |
| C205022 | Individual Weight |
| C205017 | Group Weight |
| C205209 | Average Weight |
| C205053 | Weight Variation |
| C205021 | Individual Fill Weight |
| C205016 | Group Fill Weight |
| C205206 | Average Fill Weight |
| C205045 | Target Group Weight Gain % |
| C205036 | Shell Weight |
| C205011 | Orifice Location |
| C205010 | Orifice Diameter |
| C205009 | Orifice Depth |
| C205037 | Drilled Side (Single or Double) |
| C205025 | Number of Orifices |
| C205034 | Ribbon Thickness |
| C205033 | Ribbon Density |
| C205035 | Seam Thickness |
| C205005 | Lock Length |
| C205044 | Tablet/Capsule Length |
| C205043 | Tablet/Capsule Diameter |
| C205042 | Tablet Thickness |
| C134266 | Tap Density |
| C205049 | Transdermal Properties |
| C133979 | Viscosity/Rheological Properties |
| C134267 | Plume Geometry |
| C134269 | Polymorphism |
| C205030 | Porosity |
| C134270 | Potency |
| C133983 | Pyrogenicity/Endotoxin |
| C134272 | Reconstitution Time |
| C133985 | Redispersibility |
| C205032 | Refractive Index |
| C134276 | Residue on Ignition |
| C134277 | Spray Pattern |
| C134278 | Sterility |
| C134113 | Syringe Functionality |
| C134114 | Total Organic Carbon |
| C200004 | Cytotoxicity |
| C205023 | Mechanical Integrity |
| C205041 | Surface Area |
| C18951 | Post-translational Modifications |
| C16643 | Glycosylation |
| C205054 | Thrombin Peptide Map |
| C205031 | Sialylation |
| C205002 | Amidation |
| C205008 | Deamidation |
| C205000 | Functional Assays |
| C205013 | Elemental Analysis |
| C74723 | Turbidity |
| C204971 | Impurity |
| C205039 | Specified Identified Impurity |
| C205040 | Specified Unidentified Impurity |
| C205052 | Unspecified Impurity |
| C205047 | Total Impurities |
| C205048 | Total Unknown Impurities |
| C205051 | Identified Impurity under IT, Monitored as Unspecified |
| C205014 | Elemental Impurity |
| C204890 | Impurity Chemical |
| C134254 | Impurities/Degradation Products/Related Substances |
| C134002 | Residual Solvent |
Source
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"resourceType": "ValueSet",
"id": "pqcmc-test-category-terminology",
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"identifier": [
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"version": "2.0.0",
"name": "PqcmcTestCategoryTerminology",
"title": "Test Category Terminology",
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"date": "2025-07-03T13:07:08+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
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"description": "Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.",
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"concept": [
{
"code": "C60819",
"display": "Assay"
},
{
"code": "C204845",
"display": "Active Ingredient Content"
},
{
"code": "C205001",
"display": "Adventitious Agents (Safety)"
},
{
"code": "C81183",
"display": "Amino Acid Content"
},
{
"code": "C205003",
"display": "Bioburden"
},
{
"code": "C205007",
"display": "Counterion Content"
},
{
"code": "C205015",
"display": "Excipient"
},
{
"code": "C205018",
"display": "Host Cell DNA"
},
{
"code": "C205020",
"display": "In Vitro or In Vivo Test for Viral Contaminants"
},
{
"code": "C205028",
"display": "Percent Conjugate"
},
{
"code": "C62352",
"display": "Purity"
},
{
"code": "C171277",
"display": "Nucleic Acid Content"
},
{
"code": "C205038",
"display": "Solvate Content"
},
{
"code": "C64858",
"display": "Total Protein"
},
{
"code": "C205006",
"display": "Cell and Gene Therapy Product Characterization Assay"
},
{
"code": "C134249",
"display": "Container Closure Integrity"
},
{
"code": "C134250",
"display": "Uniformity"
},
{
"code": "C205004",
"display": "Blend Uniformity"
},
{
"code": "C205019",
"display": "IPC Content Uniformity"
},
{
"code": "C134115",
"display": "Uniformity of Dosage Unit"
},
{
"code": "C205050",
"display": "Uniformity in Containers"
},
{
"code": "C133961",
"display": "Deliverable Volume/Fill Volume"
},
{
"code": "C205026",
"display": "Organoleptic"
},
{
"code": "C138990",
"display": "Description/Appearance"
},
{
"code": "C139027",
"display": "Odor"
},
{
"code": "C134262",
"display": "Color of Solution"
},
{
"code": "C134261",
"display": "Clarity of Solution"
},
{
"code": "C138993",
"display": "Identification"
},
{
"code": "C134252",
"display": "Disintegration"
},
{
"code": "C134253",
"display": "Dissolution"
},
{
"code": "C205012",
"display": "Droplet Size"
},
{
"code": "C193381",
"display": "Foreign and Particulate Matter"
},
{
"code": "C205024",
"display": "Metal Detection"
},
{
"code": "C134255",
"display": "Loss on Drying"
},
{
"code": "C134256",
"display": "Microbial Limits"
},
{
"code": "C205027",
"display": "Osmolality/Osmolarity"
},
{
"code": "C134257",
"display": "Particle Size Distribution"
},
{
"code": "C134260",
"display": "Bulk Density"
},
{
"code": "C134263",
"display": "Conductivity"
},
{
"code": "C133974",
"display": "Crystallinity"
},
{
"code": "C133975",
"display": "Friability"
},
{
"code": "C134264",
"display": "Hardness"
},
{
"code": "C63394",
"display": "Melting Point"
},
{
"code": "C103201",
"display": "Optical Rotation"
},
{
"code": "C205029",
"display": "pH"
},
{
"code": "C60821",
"display": "Solubility"
},
{
"code": "C64832",
"display": "Specific Gravity"
},
{
"code": "C25483",
"display": "Material Properties/Measurements"
},
{
"code": "C205022",
"display": "Individual Weight"
},
{
"code": "C205017",
"display": "Group Weight"
},
{
"code": "C205209",
"display": "Average Weight"
},
{
"code": "C205053",
"display": "Weight Variation"
},
{
"code": "C205021",
"display": "Individual Fill Weight"
},
{
"code": "C205016",
"display": "Group Fill Weight"
},
{
"code": "C205206",
"display": "Average Fill Weight"
},
{
"code": "C205045",
"display": "Target Group Weight Gain %"
},
{
"code": "C205036",
"display": "Shell Weight"
},
{
"code": "C205011",
"display": "Orifice Location"
},
{
"code": "C205010",
"display": "Orifice Diameter"
},
{
"code": "C205009",
"display": "Orifice Depth"
},
{
"code": "C205037",
"display": "Drilled Side (Single or Double)"
},
{
"code": "C205025",
"display": "Number of Orifices"
},
{
"code": "C205034",
"display": "Ribbon Thickness"
},
{
"code": "C205033",
"display": "Ribbon Density"
},
{
"code": "C205035",
"display": "Seam Thickness"
},
{
"code": "C205005",
"display": "Lock Length"
},
{
"code": "C205044",
"display": "Tablet/Capsule Length"
},
{
"code": "C205043",
"display": "Tablet/Capsule Diameter"
},
{
"code": "C205042",
"display": "Tablet Thickness"
},
{
"code": "C134266",
"display": "Tap Density"
},
{
"code": "C205049",
"display": "Transdermal Properties"
},
{
"code": "C133979",
"display": "Viscosity/Rheological Properties"
},
{
"code": "C134267",
"display": "Plume Geometry"
},
{
"code": "C134269",
"display": "Polymorphism"
},
{
"code": "C205030",
"display": "Porosity"
},
{
"code": "C134270",
"display": "Potency"
},
{
"code": "C133983",
"display": "Pyrogenicity/Endotoxin"
},
{
"code": "C134272",
"display": "Reconstitution Time"
},
{
"code": "C133985",
"display": "Redispersibility"
},
{
"code": "C205032",
"display": "Refractive Index"
},
{
"code": "C134276",
"display": "Residue on Ignition"
},
{
"code": "C134277",
"display": "Spray Pattern"
},
{
"code": "C134278",
"display": "Sterility"
},
{
"code": "C134113",
"display": "Syringe Functionality"
},
{
"code": "C134114",
"display": "Total Organic Carbon"
},
{
"code": "C200004",
"display": "Cytotoxicity"
},
{
"code": "C205023",
"display": "Mechanical Integrity"
},
{
"code": "C205041",
"display": "Surface Area"
},
{
"code": "C18951",
"display": "Post-translational Modifications"
},
{
"code": "C16643",
"display": "Glycosylation"
},
{
"code": "C205054",
"display": "Thrombin Peptide Map"
},
{
"code": "C205031",
"display": "Sialylation"
},
{
"code": "C205002",
"display": "Amidation"
},
{
"code": "C205008",
"display": "Deamidation"
},
{
"code": "C205000",
"display": "Functional Assays"
},
{
"code": "C205013",
"display": "Elemental Analysis"
},
{
"code": "C74723",
"display": "Turbidity"
},
{
"code": "C204971",
"display": "Impurity"
},
{
"code": "C205039",
"display": "Specified Identified Impurity"
},
{
"code": "C205040",
"display": "Specified Unidentified Impurity"
},
{
"code": "C205052",
"display": "Unspecified Impurity"
},
{
"code": "C205047",
"display": "Total Impurities"
},
{
"code": "C205048",
"display": "Total Unknown Impurities"
},
{
"code": "C205051",
"display": "Identified Impurity under IT, Monitored as Unspecified"
},
{
"code": "C205014",
"display": "Elemental Impurity"
},
{
"code": "C204890",
"display": "Impurity Chemical"
},
{
"code": "C134254",
"display": "Impurities/Degradation Products/Related Substances"
},
{
"code": "C134002",
"display": "Residual Solvent"
}
]
}
]
}
}
FHIR