SF - Quality Control Labs
Laboratory Details
University of Nairobi, School of Pharmacy Building, 2nd Floor / PO Box 29726, Kenyatta National Hospital Complex, Hospital Road
Nairobi,
KNH-00202
Kenya
Product Details
WHO Product ID
Kenya-NQCL
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
National Quality Control Laboratory (NQCL)
University of Nairobi, School of Pharmacy Building, 2nd Floor / PO Box 29726, Kenyatta National Hospital Complex, Hospital Road
Nairobi,
KNH-00202
Kenya
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Microbiological Testing | Sterility test, microbial purity, bacterial endotoxins test (LAL), microbial assay | Microbial purity, microbial assay |
| Identification | FTIR, HPLC (UV-VIS detection), AAS, UV-VIS spectrophotometry | FTIR, HPLC (UV-VIS detection), AAS, UV-VIS spectrophotometry |
| Assay, Impurities and related substances | HPLC (UV-VIS detection), UV-VIS spectrophotometry, AAS, volumetric titrations, polarimetry. Determination of related substances/impurities and degradation products | HPLC (UV-VIS detection), UV-VIS spectrophotometry, AAS, volumetric titrations, polarimetry. Determination of related substances/impurities and degradation products |
| Physical/Chemical analysis | pH, loss on drying, water content, friability, disintegration, dissolution, density | pH, loss on drying, water content, density, melting point |