SF - Quality Control Labs
Laboratory Details
No. 28 Gaoxin Central 2nd Avenue, Shenzhen High-Tech Zone, NanShan District
Shenzhen,
Guangdong
518057
China
Product Details
WHO Product ID
China - SZIDC
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Shenzhen Institute for Drug Control
No. 28 Gaoxin Central 2nd Avenue, Shenzhen High-Tech Zone, NanShan District
Shenzhen,
Guangdong
518057
China
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (UV-Vis, Fluorescence and Refractive index detection), GC with headspace (FID, TCD), TLC, UV- Vis spectrophotometry, AAS, IR, Volumetric titrations. | HPLC (UV-Vis, Fluorescence and Refractive index detection), GC with headspace (FID, TCD), TLC, UV- Vis spectrophotometry, AAS, IR, Volumetric titrations. |
| Identification | HPLC (UV-Vis, Refractive index detection, Fluroscence), GC with headspace (FID), TLC, IR, basic tests. | HPLC (UV-Vis, Refractive index detection, Fluorescence), GC with headspace (FID), TLC, IR, basic tests. |
| Physical/Chemical analysis | pH, Density, Refractometry, Water content, Limit tests, Disintegration time, Dissolution, Uniformity of dosage units (by mass or content), Friability, Uv-Vis. | pH, Refractometry, Optical rotation, Loss on drying, Water content, Heavy metals, Acid Value, Iodine value, Limit tests, Nitrogen determination, UV-Vis. |