SF - Quality Control Labs
Laboratory Details
14 Antona Tsedika Street
Kiev,
3680
Ukraine
Product Details
WHO Product ID
Ukraine-LPA
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Laboratory of Pharmaceutical Analysis, State Expert Centre, Ministry of Health of Ukraine
14 Antona Tsedika Street
Kiev,
3680
Ukraine
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (UV-Vis, DAD, fluorescense, RI detection), GC, UV-Vis spectrophotometry, AAS, volumetric titrations | HPLC (UV-Vis, DAD, fluorescense, RI detection), GC, UV-Vis spectrophotometry, AAS, volumetric titrations |
| Identification | HPLC (UV-Vis, DAD, fluorescense, RI detection), GC, TLC, UV-Vis and NIR spectrophotometry, AAS, basic tests | HPLC (UV-Vis, DAD, fluorescense, RI detection), GC, TLC, UV-Vis and NIR spectrophotometry, AAS, basic tests |
| Physical/Chemical analysis | pH, density, refractometry, optical rotation, viscosity, conductivity, water content, acid value, iodine value, peroxide value, ester value, hydroxyl value, saponification value, nitrogen determination, heavy metals, loss on drying, limit tests, disintegration, dissolution, uniformity of dosage units (mass, content), friability, tablet hardness, dimensions | pH, density, refractometry, optical rotation, viscosity, conductivity, melting point, water content, acid value, iodine value, peroxide value, ester value, hydroxyl value, saponification value, acid neutralizing capacity, nitrogen determination, heavy metals, loss on drying, limit tests |
| 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 |