SF - Quality Control Labs
Laboratory Details
Elmansoniya Street, Haram,
Giza,
Egypt
Product Details
WHO Product ID
EGYPT - EDA-CADC
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Egyptian Drug Authority - Central Adminstration for Drug Control
Elmansoniya Street, Haram
Giza,
Egypt
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Physical/Chemical analysis | pH, Water content by Karl Fischer (semi-micro method), Friability, Hardness, Disintegration, Dissolution, Uniformity of dosage units (mass variation, content uniformity), Residual solvents | pH, Water content by Karl Fischer (semi-micro method), Residual solvents |
| Identification | HPLC (UV-Vis, DAD detection), UV-Vis Spectrophotometry | HPLC (UV-Vis, DAD detection), UV-Vis Spectrophotometry |
| Assay, Impurities and related substances | HPLC (UV-Vis, DAD detection), GC (FID detection), UV-Vis Spectrophotometry | HPLC (UV-Vis, DAD detection), GC (FID detection), UV-Vis Spectrophotometry, Residual solvents |
| Microbiological Testing | Bacterial endotoxins test (Gel-clot method) | Bacterial endotoxins test (Gel-clot method) |