SF - Quality Control Labs
Laboratory Details
Biopole Clemont-Limagne
Saint Beauzire,
F-63360
France
Product Details
WHO Product ID
France - APTYS
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Aptys Pharmaservices
Biopole Clemont-Limagne
Saint Beauzire,
F-63360
France
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, amperometric detectio, RI), UV-VIS spectrophotometry, volumetric titrations, Potentiometry. | HPLC (UV-VIS detection, amperometric detection, RI), DAD, UV-VIS spectrophotometry, volumetric titrations, Potentiometry. |
| Stability testing | Under ICH Conditions | Under ICH Conditions |
| Physical/Chemical analysis | pH, density, water content (Karl Fischer), friability, disintegration, tablet hardness, dissolution, viscosity, dimensions, uniformity of dosage unit (mass, content), extractable volume, average volume. | pH, Water content (Karl Fischer), loss on drying, viscosity, limit tests ,solubility, conductivity. |
| Identification | HPLC (UV-VIS detection, amperometric detection, RI), DAD, FTIR, UV-VIS spectrophotometry, TLC, chemical reaction (basic tests). | HPLC (UV-VIS detection, amperometric detection, RI), DAD, FTIR, UV-VIS spectrophotometry, TLC, chemical reaction (basic tests). |