SF - Quality Control Labs
Laboratory Details
Chemical-Pharmaceuticals No. 2 and Antibiotics for Control and Coordination; Biotechnological; Nano-medicines, Cell & Gene Therapy; Vitamins; Hormones-Synthetic Analogues; and Microbiology Laboratories; Schukinskaya Street 6/1
Moscow,
117 246
Russian Federation
Product Details
WHO Product ID
Russia-FSBI SCEEMP
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Federal Service for Surveillance in Healthcare "Scientific Centre for Expert Evaluation of Medicinal Products" (SCEEMP)
Petrovskiy Bulvar, 8
Moscow,
127 051
Russian Federation
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Microbiological Testing | Microbial limit tests | Microbial limit tests |
| Identification | HPLC (UV-Vis, PDA, RI, detection), GC (FID, ECD, TCD), TLC, UV-VIS spectrophotometry, IR, basic tests | HPLC (UV-Vis, PDA, RI, detection), GC (FID, ECD, TCD), TLC, UV-VIS spectrophotometry, IR, basic tests |
| Assay, Impurities and related substances | HPLC (UV-Vis, PDA, RI detection), GC (FID, ECD, TCD), UV-Vis spectrophotometry,FTIR, volumetric titrations | HPLC (UV-Vis, PDA, RI, detection), LC/MS, GC (FID, ECD, TCD), UV-Vis spectrophotometry, FTIR, volumetric titrations |
| Physical/Chemical analysis | pH, density, refractive index, optical rotation, water content, residual solvents, limit tests, disintegration, dissolution, uniformity of dosage units (mass, content) | pH, refractometry, refractive index, optical rotation, viscosity, melting point, loss on drying, water content, heavy metals, residual solvents and limit tests |