SF - Quality Control Labs
Laboratory Details
No 31 Imam Khomeini Avenue
Tehran,
11136-15911
Iran, Islamic Rep.
Product Details
WHO Product ID
Iran-FDCL
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Food and Drugs Control Refence Laboratories (FDCRL), Ministry of Health and Medical Education
No 31 Imam Khomeini Avenue
Tehran,
11136-15911
Iran, Islamic Rep.
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Physical/Chemical analysis | pH, water content, loss on drying, friability, disintegration, tablet hardness, dissolution, viscosity, density, dimensions, uniformity of dosage unit (mass, content). | pH, Water content, loss on drying, refractive index, optical rotation, viscosity, melting point, heavy metals, sulphated ash, residual solvents, limit tests ,solubility, Conductivity, Organic Volatile Impurities (OVI). |
| Microbiological Testing | Sterility test, microbial limit tests, microbial assay of antibiotics, Bacterial Endotoxins Tests (LAL test) | Bacterial Endotoxins Tests (LAL test) |
| Identification | HPLC (UV-VIS detection, RI, fluorescence detection), GC-MS, IR, FTIR, UV-VIS spectrophotometry, TLC, chemical reaction (basic tests) | HPLC (UV-VIS detection, RI, fluorescence detection), GC-MS, IR, FTIR, UV-VIS spectrophotometry, TLC, chemical reaction (basic tests) |
| Assay, Impurities and related substances | HPLC (UV-VIS detection, RI, fluorescence detection), UV-VIS spectrophotometry, GC (FID, TCD), AAS, ICP-MS, Fluorimetry, gravimetric analysis, volumetric titrations, Potentiometry. | HPLC (UV-VIS detection, RI, fluorescence detection), UV-VIS spectrophotometry, GC (FID, TCD), AAS, ICP-MS, Fluorimetry, gravimetric analysis, volumetric titrations, Potentiometry. |