SF - Quality Control Labs
Laboratory Details
Private Bag X 69, Bryanston 2021, 1 Sabax Road, Aeroton
Johannesburg,
2013
South Africa
Product Details
WHO Product ID
South Africa - Adcock R+D
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Adcock Ingram Ltd Research & Development
Private Bag X 69, Bryanston 2021, 1 Sabax Road, Aeroton
Johannesburg,
2013
South Africa
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, UV, AA and FTIR spectrophotometry and volumetric titrations. Determination of related substances and impurities by comparison with a reference standard | HPLC (UV-VIS, DAD, RI detection), GC, UV, AA and FTIR spectrophotometry, polarimetry and volumetric titrations. Determination of related substances and impurities by comparison with a reference standard |
| Identification | IR, TLC, HPLC, AA, spectrophotometry and basic tests | IR, TLC, HPLC, spectrophotometry and basic tests |
| Stability testing | ICH conditions | n/a |
| Physical/Chemical analysis | pH, water content, loss on drying, friability, disintegration time, tablet hardness, dissolution, AA, viscosity, density, dimensions | pH, water content, melting point, loss on drying, refractometry |