SF - Quality Control Labs
Laboratory Details
Plot No A-772/773, MIDC, TTC Industrial Area, Navi Mumbai
Koparkhairane,
Maharashtra
400 701
India
Product Details
WHO Product ID
India - SGS - Mumbai
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
SGS India Pvt Ltd - Life Science
Plot No A-772/773, MIDC, TTC Industrial Area, Navi Mumbai
Koparkhairane,
Maharashtra
400 701
India
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC, GC, UV-VIS spectrophotometry, FTIR, Volumetric titrations. | HPLC, GC, UV-VIS spectrophotometry, FTIR, Volumetric titrations. |
| Identification | HPLC, GC, TLC, UV-VIS spectrophotometry, FTIR, basic tests. | HPLC, GC, TLC, UV-VIS spectrophotometry, FTIR, basic tests. |
| Microbiological Testing | Microbial limit tests, Bacterial endotoxins test (LAL), preservative effectiveness test, microbial assay of antibiotics, Particulate Matter. | Microbial limit tests, Bacterial endotoxins test (LAL), microbial assay of antibiotics, Particulate Matter. |
| Physical/Chemical analysis | pH, water content, Loss on drying, Limit tests, hardness, friability, disintegration, dissolution, viscosity, uniformity of dosage units (mass, content), optical rotation. | pH, melting point, Loss on drying, heavy metals, water content, Limit tests, Specific optical rotation. |
| Stability testing | ICH conditions | ICH conditions |