SF - Quality Control Labs
Laboratory Details
10G Kudryavskaya Street
Kiev,
4053
Ukraine
Product Details
WHO Product ID
Ukraine-CLQCM
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Central Laboratory for Quality Control of Medicines and Medical Products, State Drug Administration of Ukraine
10G Kudryavskaya Street
Kiev,
4053
Ukraine
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Microbiological Testing | Sterility test, microbial limit tests, bacterial endotoxins test (LAL), microbial assay of antibiotics | Sterility test, microbial limit tests, bacterial endotoxins test (LAL), microbial assay of antibiotics |
| Identification | HPLC (UV-Vis, RI detection), GC (FID), TLC, UV-VIS spectrophotometry, FTIR, basic tests | HPLC (UV-Vis, RI detection), GC (FID), TLC, UV-VIS spectrophotometry, FTIR, basic tests |
| Assay, Impurities and related substances | HPLC (UV-Vis, RI detection), GC (FID), UV-Vis spectrophotometry, AAS, FTIR, volumetric titrations | HPLC (UV-Vis, RI detection), GC (FID), UV-Vis spectrophotometry, AAS, FTIR, volumetric titrations |
| Physical/Chemical analysis | pH, density, refractometry, viscosity, water content, limit tests, disintegration, dissolution, uniformity of dosage units (mass, content), friability, dimensions | pH, refractometry, viscosity, loss on drying, water content, heavy metals, acid value, iodine value, limit tests, acid neutralizing capacity, distilling range, nitrogen determination |