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 |
|---|---|---|
| Identification | IR, TLC, HPLC, UV-Vis, Spectrophotometry and basic tests. | IR, TLC, HPLC, UV-Vis, Spectrophotometry and basic tests. |
| Assay, Impurities and related substances | HPLC (UV-VIS detection, RI, fluorescence detection, conductivity, PDA), UPLC (PDA), GC-MS, UV-VIS spectrophotometry, potentiometric and volumetric titration, Determination of related substances/impurities and degradation products. | HPLC (UV-VIS detection, RI, fluorescence detection, conductivity, PDA), UPLC (PDA), GC-MS, UV-VIS spectrophotometry, potentiometric and volumetric titration, Determination of related substances/impurities and degradation products. |
| Microbiological Testing | Microbial Limit Tests, Microbial assay of antibiotics, Preservative Efficacy Test. | Microbial Limit Tests, Microbial assay of antibiotics. |
| Stability testing | ICH Conditions | ICH Conditions |
| Physical/Chemical analysis | pH, water content, loss on drying, water content (Karl Fischer), friability, disintegration time of tablets, hardness, dissolution, viscosity, density, Uniformity of Dosage Units. | pH, water content, loss on drying, water content (Karl Fischer), melting point, conductivity. |