SF - Quality Control Labs
Laboratory Details
Ministry of Health & Family Welfare, Sector 23, Raj Nagar
Ghaziabad,
Uttar Pradesh
201002
India
Product Details
WHO Product ID
India-IPL
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Indian Pharmacopoiea Commission - Indian Pharmacopoeial Laboratory
Ministry of Health & Family Welfare, Sector 23, Raj Nagar
Ghaziabad,
Uttar Pradesh
201002
India
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Identification | IR, HPLC (UV-VIS detection), UV-VIS spectrophotometry, LC-MS, NMR, AAS, CHNSO analysis | FTIR, HPLC (UV-VIS detection), UV-VIS spectrophotometry, NMR, AAS, CHNSO analysis |
| Assay, Impurities and related substances | HPLC (UV-VIS detection), GC, GC-MS, AA, UV-VIS spectrophotometry, volumetric titrations, polarimetry | HPLC (UV-VIS detection), GC. GC-MS, AA, UV-VIS spectrophotometry, volumetric titrations, polarimetry |
| Assay, Impurities and related substances | Determination of related substances/impurities and degradation products | Determination of related substances/impurities and degradation products |
| Microbiological Testing | Sterility test, microbial limit tests, bacterial endotoxins test (LAL), preservative efficacy test, microbial assay of antibiotics | Sterility test, microbial limit tests, bacterial endotoxins test (LAL), preservative efficacy test, microbial assay of antibiotics |
| Physical/Chemical analysis | pH, loss on drying, water content, density, friability, dissolution, uniformity of dosage units (mass, content) | pH, loss on drying, water content, density, melting point, thermal analysis (DSC) and optical rotation |