SF - Quality Control Labs
Laboratory Details
Unit 1, Plot No 187, 2nd Phase GIDC
Vapi,
Gujarat
396 195
India
Product Details
WHO Product ID
Portugal - Laboratorios Basi
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Laboratorios Basi - Industria Farmaceutica SA
Rua do Padrão 98
Coimbra,
3000-312
Portugal
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (UV-Vis, RI, DAD), GC (FID, µECD), UV-Vis spectrophotometry, FTIR/NIR, potentiometry, volumetric titrations, gravimetry | HPLC (UV-Vis, RI, DAD), GC (FID, µECD), UV-Vis spectrophotometry, FTIR/NIR, potentiometry, volumetric titrations, gravimetry |
| Identification | HPLC (UV-Vis, RI, DAD), GC (FID, µECD), TLC, UV-Vis spectrophotometry, FTIR/NIR | HPLC (UV-Vis, RI, DAD), GC (FID, µECD), TLC, UV-Vis spectrophotometry, FTIR/NIR |
| Microbiological Testing | Sterility test, microbial limit tests, bacterial endotoxins test (LAL), microbial assay of antibiotics, preservative efficacy test | Sterility test, microbial limit tests, bacterial endotoxins test (LAL), microbial assay of antibiotics, preservative efficacy test |
| Physical/Chemical analysis | pH, density, refractive index, optical rotation, viscosity, loss on drying, water content, conductivity, total organic carbon, tablet hardness, dimensions, friability, disintegration, dissolution, uniformity of dosage units (mass, content), particulate matter test | pH, density, refractive index, optical rotation, viscosity, melting point, loss on drying, water content, conductivity, sulphated ash, acid value, ester value, hydroxyl value iodine value, peroxide value, saponification value, total organic carbon, particulate matter test |
| Stability testing | ICH conditions | ICH conditions |