SF - Quality Control Labs
Laboratory Details
Information and Methodological Center for Expertise,, Stocktaking and Analysis of Circulation of Medical products" (FSBO-IMCESACMP), 71/63B Chentsova Street
City of Rostov-on-Don,
344037
Russian Federation
Product Details
WHO Product ID
Russia - SCEEMP Rostov
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Rostov-on-Don Branch of Federal Service for Surveillance in Healthcare
Information and Methodological Center for Expertise,, Stocktaking and Analysis of Circulation of Medical products" (FSBO-IMCESACMP), 71/63B Chentsova Street
City of Rostov-on-Don,
344037
Russian Federation
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) |
| Identification | HPLC (UV-Vis, RI, DAD detection), GC (FID, TCD), TLC, UV-VIS spectrophotometry, IR, basic tests | HPLC (UV-Vis, RI, DAD detection), GC (FID, TCD), TLC, UV-VIS spectrophotometry, IR, basic tests |
| Assay, Impurities and related substances | HPLC (UV-Vis, RI, DAD detection), GC (FID, TCD), UV-Vis spectrophotometry, volumetric titrations | HPLC (UV-Vis, RI, DAD detection), GC (FID, TCD), UV-Vis spectrophotometry, volumetric titrations |
| Physical/Chemical analysis | pH, density, refractive index, optical rotation, water content, loss on drying, residual solvents, limit tests, disintegration, dissolution, uniformity of dosage units (mass, content) | pH, density, refractive index, optical rotation, water content, loss on drying, residual solvents, limit tests |