SF - Quality Control Labs
Laboratory Details
1 Chemin de Saulxier, Longjumeau
Paris,
91160
France
Product Details
WHO Product ID
France - Gimopharm
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Gimopharm Sarl
1 Chemin de Saulxier, Longjumeau
Paris,
91160
France
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Stability testing | ICH Conditions | ICH Conditions |
| Physical/Chemical analysis | pH, density, refractive index, optical rotation, osmolality, water content, residual solvents, limit tests, tablet hardness, friability, disintegration, dissolution, viscosity, uniformity of dosage units (mass, content), particle size (laser,) Differential scanning calorimetry, X-ray Diffraction. | pH, density, refractive index, optical rotation, osmolarity, water content, residual solvents, limit tests, particle size, Total Organic Carbon, conductivity, viscosity, heavy metals, Ash, sulfated ash, Differential scanning calorimetry, X-ray Diffraction. |
| Microbiological Testing | Microbial limit tests, Bacterial endotoxins test (LAL); Challenge Test. | Microbial limit tests, Bacterial endotoxins test (LAL). |
| Stability testing | All ICH conditions | All ICH conditions |
| Assay, Impurities and related substances | GC-FID/ MS-MS, HPLC-UV/ PDA/ MS-MS/ MS/Fluo/ RI / ELSD, UPLC-MS, Ionic, ICP/MS, AAS. | GC- FID/ MS-MS , HPLC-UV/ PDA/ MS-MS/ MS/ Fluo/ RI / ELSD, UPLC-MS, Ionic, ICP/MS, AAS, Post column derivatization. |
| Identification | HPLC (UV-VIS, DAD, RI fluorescence detection), TLC, GC, UV-VIS spectrophotometry, IR, AAS, fluorimetry, MS, MS-MS. | HPLC (UV-VIS, DAD, RI, fluorescence detection), TLC, GC, UV-VIS spectrophotometry, IR, AAS, fluorimetry. |