SF - Quality Control Labs
Laboratory Details
48 Hai Ba Trung Street, Hoan Kiem District
Hanoi,
Vietnam
Product Details
WHO Product ID
Vietnam-NIDQC
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
National Institute of Drug Quality Control (NIDQC)
48 Hai Ba Trung Street, Hoan Kiem District
Hanoi,
Vietnam
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, fluorescence, light scattering detection), LC/MS/MS, GC (FID, ECD), GC/MS, TLC, HPTLC, UV-VIS spectrophotometry, AAS, fluorimetry, volumetric titrations, amperometry, potentiometry, nitrogen assay | HPLC (UV-Vis, DAD, fluorescence, light scattering detection), LC/MS/MS, GC (FID, ECD), GC/MS, TLC, HPTLC, UV-VIS spectrophotometry, AAS, fluorimetry, volumetric titrations, amperometry, potentiometry, nitrogen assay, thermal analysis (DSC) |
Stability testing | WHO conditions | WHO conditions |
Physical/Chemical analysis | pH, density, refractometry, viscosity, loss on drying, water content, disintegration, dissolution, uniformity of dosage units (mass, content), friability, tablet hardness, particulate matter test. | pH, density, refractometry, specific optical rotation, viscosity, loss on drying, melting point, water content, heavy metals, sulphated ash, acid insoluble ash, acid value, iodine value, ester value, acetyl value, peroxide value, saponification value. |
Microbiological Testing | Sterility test, microbial purity, test for pyrogens, bacterial endotoxins test (LAL), microbial assay. | Microbial assay |
Identification | HPLC (UV-Vis, DAD, fluorescence, light scattering detection), LC/MS/MS, GC (FID, ECD), GC/MS, TLC, HPTLC, UV-VIS spectrophotometry, IR, AAS | HPLC (UV-Vis, DAD, fluorescence, light scattering detection), LC/MS/MS, GC (FID, ECD), GC/MS, TLC, HPTLC, UV-VIS spectrophotometry, IR, FTIR, AAS, chemical reaction |