| Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
| resourceType | ValueSet |
| id | pqcmc-test-category-terminology |
| canonical | http://hl7.org/fhir/us/pq-cmc/ValueSet/pqcmc-test-category-terminology |
| version | 0.1.15 |
| status | draft |
| publisher | HL7 International - Biomedical Research and Regulatory WG |
| name | PqcmcTestCategoryTerminology |
| title | Test Category Terminology |
| date | 2023-07-17T03:00:13+00:00 |
| experimental | true |
| description | Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. |
| jurisdictions | us |
| Usages |
|
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
| Code | Display |
| TC1 | Assay |
| TC3 | Container Closure Integrity |
| TC4 | Uniformity |
| TC5 | Deliverable Volume/Fill Volume |
| TC6 | Organoleptic |
| TC7 | Identification |
| TC8 | Disintegration |
| TC9 | Dissolution |
| TC10 | Droplet Size |
| TC11 | Foreign and Particulate Matter |
| TC12 | Loss on Drying |
| TC13 | Microbial Limits |
| TC14 | Osmolality/ Osmolarity |
| TC15 | Particle Size Distribution |
| TC16 | Bulk Density |
| TC17 | Conductivity |
| TC18 | Crystallinity |
| TC19 | Friability |
| TC20 | Hardness |
| TC21 | Melting Point |
| TC22 | Optical Rotation |
| TC23 | pH |
| TC24 | Solubility |
| TC25 | Specific Gravity |
| TC26 | Material Properties/Measurements |
| TC27 | Tap Density |
| TC28 | Transdermal Properties |
| TC29 | Viscosity/ Rheological Properties |
| TC30 | Plume Geometry |
| TC31 | Polymorphism |
| TC32 | Porosity |
| TC33 | Potency |
| TC34 | Pyrogenicity/Endotoxin (test example – rabbit test name) |
| TC35 | Reconstitution Time |
| TC36 | Redispersibility |
| TC37 | Refractive Index |
| TC38 | Residue on Ignition |
| TC39 | Spray Pattern |
| TC40 | Sterility |
| TC41 | Syringe Functionality |
| TC42 | Total Organic Carbon |
| TC46 | Mechanical Integrity |
| TC47 | Surface Area |
| TC48 | Post-translational modifications |
| TC49 | Functional Assays |
| TC50 | Elemental Analysis |
| TC51 | Turbidity |
| TC53 | Impurity |
Produced 08 Sep 2023