SF - Quality Control Labs
Laboratory Details
3BM-416, 3rd Block, HRBR Extension
Bangalore,
Karnataka
560 043
India
Product Details
WHO Product ID
India - Stabicon
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Stabicon Life Sciences Pvt Ltd
3BM-416, 3rd Block, HRBR Extension
Bangalore,
Karnataka
560 043
India
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (UV-VIS, DAD, RI detection), GC (FID), TLC, UV-VIS spectrophotometry, volumetric titrations. Determination of related substances/impurities, degradation products and residual solvents | HPLC (UV-VIS, DAD, RI detection), GC (FID), TLC, UV-VIS spectrophotometry, volumetric titrations.Determination of related substances/impurities, degradation products |
| Identification | TLC, HPLC (UV-VIS, DAD, RI), GC (FID), UV-VIS spectrophotometry, basic tests | TLC, HPLC (UV-VIS, DAD, RI), GC (FID), UV-VIS spectrophotometry, basic tests |
| Stability testing | ICH conditions | ICH conditions |
| Physical/Chemical analysis | pH, loss on drying, water content (Karl Fischer), friability, disintegration, dissolution, density, tablet hardness, uniformity of dosage units (mass, content) | pH, loss on drying, water content (Karl Fischer), heavy metals, limit tests |
| Microbiological Testing | Microbial limit tests, preservative efficacy test, microbial assay of antibiotics | Microbial limit tests, preservative efficacy test, microbial assay of antibiotics |