SF - Quality Control Labs
Laboratory Details
No 1500, Zhangheng Road, Zhangjiang High-Tech Park, Pudong New Area
Shanghai,
201203
China
Product Details
WHO Product ID
China - SIFDC (Drug Quality Control Center)
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Shanghai Institute for Food and Drug Control
No 1500, Zhangheng Road, Zhangjiang High-Tech Park, Pudong New Area
Shanghai,
201203
China
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC（UV, DAD, RI, FLD), GC(FID),TLC, UV-VIS, IR, AAS, Volumetric titrations, Potentiometric titrations. | HPLC（UV, DAD, RI, FLD), GC(FID),TLC, UV-VIS, IR, AAS, Volumetric titrations, Potentiometric titrations. |
| Identification | HPLC（UV, DAD, RI, FLD), GC(FID), TLC, UV-VIS, IR, Specific rotation (Optical rotation), Melting point (Melting range), Basic tests. | HPLC（UV, DAD, RI, FLD), GC(FID), TLC, UV-VIS, IR, Specific rotation (Optical rotation), Melting point (Melting range), Basic tests. |
| Microbiological Testing | Sterility, Microbial limits, Bacterial Endotoxins (Gel-clot method: limit test) | Sterility, Microbial limits, Bacterial Endotoxins (Gel-clot method: limit test) |
| Physical/Chemical analysis | pH, Disintegration, Dissolution, Loss on drying, Uniformity of dosage units(mass, content), Colour of solution, Clarity of solution, Water content(Karl Fischer),Visible particles, Subvisible particles, Density, Refractometry, Friability. | pH, Specific rotation(Optical rotation), Melting point(Melting range), Loss on drying, Sulfated ash, Limit tests, Colour of solution, Clarity of solution, Water content(Karl Fischer), Nitrogen determination. |