SF - Quality Control Labs
Laboratory Details
MEDS Centre / PO Box 78040, Mombasa Road, opposite Nation Printers
Nairobi,
507
Kenya
Product Details
WHO Product ID
Kenya - MEDS
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Mission for Essential Drugs & Supplies (MEDS)
MEDS Centre / PO Box 78040, Mombasa Road, opposite Nation Printers
Nairobi,
507
Kenya
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (UV-VIS detection), GC, UV-VIS spectrophotometry, volumetric titrations, polarimetry. Determination of related substances/impurities and degradation products | HPLC (UV-VIS, DAD, RID, fluorescence detection), UV-VIS spectrophotometry, GC, volumetric titrations, polarimetry, Determination of related substances/impurities and degradation products |
| Identification | HPLC (UV-VIS, DAD, RID, fluorescence detection), GC, UV-VIS and IR spectrophotometry, TLC, chemical reaction. | HPLC (UV-VIS, DAD, RID, fluorescence detection), GC, UV-VIS and IR spectrophotometry, TLC, chemical reaction |
| Microbiological Testing | Bacterial endotoxins test (LAL) – Kinetic Chromogenic Method | Bacterial endotoxins test (LAL) – Kinetic Chromogenic Method |
| Physical/Chemical analysis | pH, loss on drying, water content, conductivity, refractometry, friability, disintegration, dissolution, density, uniformity of dosage units (mass, content) | pH, loss on drying, water content, refractometry, density |