SF - Quality Control Labs
Laboratory Details
No. 888A, Huanghe Road, Shahekou District
Dalian City,
Liaoning
116021
China
Product Details
WHO Product ID
China - DIDC
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Dalian Institute for Drug Control
No. 888A, Huanghe Road, Shahekou District
Dalian City,
Liaoning
116021
China
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (UV-Vis, DAD, RI detection), GC (FID), UV-VIS spectrophotometry, AAS, FTIR, TLC, HPLC-MS, ion chromatography, volumetric titrations, gravimetric analysis, optical rotation, potentiometric titrations, nitrogen determination, determination of related substances/impurities and degradation products, residual solvents | HPLC (UV-Vis, DAD, RI detection), GC (FID), UV-VIS spectrophotometry, AAS, FTIR, TLC, HPLC-MS, ion chromatography, volumetric titrations, gravimetric analysis, optical rotation, potentiometric titrations, nitrogen determination, oxygen flask combustion, determination of related substances/impurities and degradation products, residual solvents |
| Identification | HPLC (UV-Vis, DAD, RI detection), GC (FID), TLC, UV-VIS spectrophotometry, FTIR, HPLC-MS, AAS, ion chromatography, basic tests | HPLC (UV-Vis, DAD, RI detection), GC (FID), TLC, UV-VIS spectrophotometry, FTIR, HPLC-MS, AAS, ion chromatography, basic tests |
| Physical/Chemical analysis | pH, density, refractometry, water content, limit tests, disintegration, dissolution, uniformity of dosage units (mass, content), friability, viscosity, extractable volume for parenteral preparations, colour of solution, clarity of solution, particulate(matter) contamination, particle size, osmolality | pH, refractometry, optical rotation, loss on drying, water content, heavy metals, acid value, iodine value, limit tests, nitrogen determination, viscosity, peroxide value, saponification value, unsaponifiable matter, hydroxyl value, distilling range, melting point, congealing point, thermal analysis, color of solution, clarity of solution, particulate(matter) contamination, osmolality, solubility, sulphated ash, residue on ignition |