SF - Quality Control Labs
Laboratory Details
Unit IV, No 136, 6th Cross, 2nd Stage, Yeshwanthpur Industrial Suburb
Bangalore,
560022
India
Product Details
WHO Product ID
India - Auriga
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Auriga Research Pvt Ltd
Unit IV, No 136, 6th Cross, 2nd Stage, Yeshwanthpur Industrial Suburb
Bangalore,
560022
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, Refractive Index detection) GC-HS-FID, GC-MS ICP-OEX, ICP-MS LC-MS/MS TLC FTIR UV-VIS spectrophometry Volumetric titrations | HPLC (UV-Vis, Refractive Index detection) GC-HS-FID, GC-MS ICP-OEX, ICP-MS LC-MS/MS TLC FTIR UV-VIS spectrophometry Volumetric titrations |
| Identification | HPLC (UV-VIS, Refractive Index detection), GC-HS-FID, TLC, FTIR, Basic tests. | HPLC (UV-VIS, Refractive Index detection), GC-HS-FID, TLC, FTIR, Basic tests. |
| Microbiological Testing | Sterility test, Microbiology purity, Bacterial endotoxin test (LAL), Microbial Assay. | Microbiology purity, Microbial Assay. |
| Physical/Chemical analysis | pH, Density, Refractometry, Water content (Karl Fischer), Limit tests, Disintegration time, Dissolution, Uniformity of dosage units (by mass or content), Friability. | pH, Refractometry, Optical Rotation, Loss on Drying, Water content (Karl Fischer), Heavy metals, Acid value, Iodine value, Limit tests, Nitrogen determination. |
| Stability testing | ICH Conditions | ICH Conditions |