SF - Quality Control Labs
Laboratory Details
P O Box 82124, Southdale, 40 Modulus Road, Ormonde
Johannesburg,
2091
South Africa
Product Details
WHO Product ID
South Africa (M and L)
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
M and L Laboratory Services (Pty) Ltd
P O Box 82124, Southdale, 40 Modulus Road, Ormonde
Johannesburg,
2091
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, fluorescence, RI, conductivity, PDA), UPLC (PDA), GC, UV, potentiometric, and volumetric titrations | HPLC (UV, fluorescence, RI, conductivity, PDA), UPLC (PDA), GC, UV, potentiometric, and volumetric titrations |
| Identification | IR, TLC, HPLC, UPLC, UV, spectrophotometry, and basic tests | IR, TLC, HPLC, UPLC, UV, spectrophotometry, and basic tests |
| Physical/Chemical analysis | pH, water content, loss on drying, water content (Karl Fischer), friability, disintegration, tablet hardness, dissolution, viscosity, density, uniformity of dosage units | pH, water content, loss on drying, water content (Karl Fischer), melting point, conductivity |
| Stability testing | ICH Conditions | ICH Conditions |