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Colombia-INVIMA

SF - Quality Control Labs
Laboratory Details
Laboratories, Avenida Calle 26 No. 51-20
Bogota,
Colombia
Product Details
WHO Product ID
Colombia-INVIMA
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
Carrera 68D No. 17-21
Bogota,
Colombia
Date of last inspection
Type of analysis Finished Products Active Pharmaceutical Ingredients
Assay, Impurities and related substances HPLC (fluorescence, UV, UV-Vis, DAD, RI detection), GC, UV, Optical Emission Spectrometry (ICP-OES) and FTIR spectrophotometry and volumetric titrations. Determination of related substances and impurities by comparison with a reference standard. HPLC (fluorescence, UV, UV-Vis, DAD, RI detection), GC, UV, Optical Emission Spectrometry (ICP-OES) and FTIR spectrophotometry and volumetric titrations. Determination of related substances and impurities by comparison with a reference standard.
Physical/Chemical analysis pH, water content (Karl Fischer), loss on drying, disintegration time, tablet hardness, dissolution, density, uniformity of dosage units (mass, content), particulate matter test. pH, water content (Karl Fischer), loss on drying, density, particulate matter test.
Identification IR, TLC, HPLC, Optical Emission Spectrometry (ICP-OES), GC spectrophotometry and basic tests. IR, TLC, HPLC, Optical Emission Spectrometry (ICP-OES), GC spectrophotometry and basic tests.