SF - Quality Control Labs
Laboratory Details
2 Tiantan Xili (Temple of Heaven)
Beijing,
Beijing
100 050
China
Product Details
WHO Product ID
China - NIFDC
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
National Institutes for Food and Drug Control (NIFDC)
2 Tiantan Xili (Temple of Heaven)
Beijing,
Beijing
100 050
China
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Identification | HPLC (UV-Vis, RI detection), GC (FID), TLC, UV-VIS spectrophotometry, FTIR, basic tests | HPLC (UV-Vis, RI detection), GC (FID), TLC, UV-VIS spectrophotometry, FTIR, basic tests |
| Microbiological Testing | Bacterial endotoxins test (LAL), microbial assay of antibiotics | Bacterial endotoxins test (LAL), microbial assay of antibiotics |
| Assay, Impurities and related substances | HPLC (UV-Vis, RI detection), GC (FID), UV-VIS spectrophotometry, AAS, FTIR, volumetric titrations | HPLC (UV-Vis, RI detection), GC (FID), UV-VIS spectrophotometry, AAS, FTIR, volumetric titrations |
| Physical/Chemical analysis | pH, density, refractometry, water content, limit tests, disintegration, dissolution, uniformity of dosage units (mass, content), friability, dimensions | pH, refractometry, optical rotation, loss on drying, water content, heavy metals, acid value, iodine value, limit tests, nitrogen determination |