SF - Quality Control Labs
Laboratory Details
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Product Details
WHO Product ID
India - Vimta (Genome V)
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Vimta Labs Ltd
Life Sciences Facility, MN Park (Formerly Alexandria Knowledge Park), Plot No 5, Genome Valley, Shamirpet Mandal, Medchal-Malkajgiri District
Hyderabad,
Telangana
500 101
India
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Microbiological Testing | Sterility test, microbial purity, bacterial endotoxins test (LAL), antimicrobial effectiveness | Sterility test, microbial purity, bacterial endotoxins test (LAL), antimicrobial effectiveness |
| Physical/Chemical analysis | pH, loss on drying, water content, friability, disintegration, dissolution, density, tablet hardness, viscosity, dimensions, uniformity of dosage units (mass, content), limit tests | pH, loss on drying, water content, density, melting point, distilling range, refractometry, acid insoluble ash, acid value, iodine value, nitrogen, limit tests, neutralizing capacity |
| Identification | FTIR, TLC, HPLC (UV-VIS, PDA, RI, fluorescence detection), UV-VIS spectrophotometry, basic tests | FTIR, TLC, HPLC (UV-VIS, PDA, RI, fluorescence detection), UV-VIS spectrophotometry, basic tests |
| Stability testing | WHO conditions | WHO conditions |
| Assay, Impurities and related substances | HPLC (UV-VIS, PDA, RI, fluorescence detection), GC (HRGC-MS, GC-MS), UV-VIS spectrophotometry, FTIR, polarimetry, AAS, ICP-MS, flame photometry, volumetric titrations | HPLC (UV-VIS, DAD, RI, fluorescence detection), GC (HRGC-MS, GC-MS), UV-VIS spectrophotometry, FTIR, polarimetry, AAS, ICP-MS, flame photometry, volumetric titrations |