SF - Quality Control Labs
Laboratory Details
North-West University, Potchefstroom Campus, Private Bag X 6001, Potchefstroom 2520, Hoffman Street
Potchefstroom,
2531
South Africa
Product Details
WHO Product ID
South Africa-RIIP
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Research Institute for Industrial Pharmacy (RIIP) incorporating CENQAM
North-West University, Potchefstroom Campus, Private Bag X 6001, Potchefstroom 2520, Hoffman Street
Potchefstroom,
2531
South Africa
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (fluorescence, UV, UV-Vis, DAD, RI detection), GC, spectrophotometry and volumetric titrations. Determination of related substances/impurities and degradation products | HPLC (fluorescence, UV, UV-Vis, DAD, RI detection), GC, spectrophotometry and volumetric titrations. Determination of related substances/impurities, degradation products and residual solvents |
| Identification | IR, TLC, HPLC, spectrophotometry and basic tests | IR, TLC, HPLC, spectrophotometry and basic tests |
| Physical/Chemical analysis | pH, water content (Karl Fischer), loss on drying, friability, disintegration, tablet hardness, uniformity of dosage units (mass, content), tablet dimensions, dissolution, AA, viscosity, density/specific gravity, redispersibility/ reconstitution time, resuspendability and sedimentation rate | pH, water content (Karl Fischer), loss on drying, X-ray diffractometry, thermal analysis (DSC, TGA) |
| Stability testing | WHO conditions | WHO conditions |