SF - Quality Control Labs
Laboratory Details
OM Marzeyev Institute for Public Health, National Academy of Medical Sciences of Ukraine, 50 Popudrenka str
Kiev,
2660
Ukraine
Product Details
WHO Product ID
Ukraine - SSRL
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
State Scientific Research Laboratory on Quality Control of Medicines
OM Marzeyev Institute for Public Health, National Academy of Medical Sciences of Ukraine, 50 Popudrenka str
Kiev,
2660
Ukraine
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (DAD, RID,UV-Vis, FLD), GC (Au/HS(FID, ECD)), UV-Vis Spectrophotometry, FTIR spectroscopy, Water determination, basic tests | HPLC (DAD, RID,UV-Vis, FLD),GC (Au/HS(FID, ECD)), UV-Vis Spectrophotometry, FTIR spectroscopy, Water determination, basic tests |
| Identification | HPLC (DAD, RID,UV-Vis, FLD), GC (FID, ECD), TLC, UV-Vis Spectrophotometry, FTIR spectroscopy, basic tests | HPLC (DAD, RID,UV-Vis, FLD), GC (FID, ECD), TLC, UV-Vis Spectrophotometry, FTIR spectroscopy, basic tests |
| Physical/Chemical analysis | Clarity and degree of opalescence of liquids, degree of coloration of liquids, pH, density, osmolality, 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, particulate contamination (sub-visible/visible particles) | pH, density, refractometry, optical rotation, viscosity, osmolality, conductivity, melting point, water content, acid value, iodine value, peroxide value, ester value, hydroxyl value, saponification value, unsaponifiable matter, nitrogen determination, heavy metals, loss on drying, limit tests |