SF - Quality Control Labs
Laboratory Details
Vieux Chemin du Poète 10
Wavre,
B-1301
Belgium
Product Details
WHO Product ID
Belgium-SGS Lab Simon
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
SGS Lab Simon SA
Vieux Chemin du Poète 10
Wavre,
B-1301
Belgium
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Microbiological Testing | Sterility test, microbial limit tests, bacterial endotoxins test (LAL), microbial assay of antibiotics. | Sterility test, microbial limit tests, bacterial endotoxins test (LAL), microbial assay of antibiotics. |
| Identification | HPLC (UV-Vis, PDA, RI, conductivity detection), GC (FID, MS), TLC, UV-VIS spectrophotometry, IR, basic tests | HPLC (UV-Vis, PDA, RI, conductivity, fluorescence detection), GC (FID, MS), TLC, UV-VIS spectrophotometry, IR, basic tests |
| Assay, Impurities and related substances | HPLC (UV-Vis, PDA, RI, conductivity detection), GC (FID), UV-Vis spectrophotometry, AAS, FTIR, volumetric titrations. | HPLC (UV-Vis, PDA, RI, conductivity detection), GC (FID), UV-Vis spectrophotometry, AAS, FTIR, volumetric titrations. |
| Physical/Chemical analysis | pH, density, refractive index, optical rotation, viscosity, water content, conductivity, residual solvents, limit tests, tablet hardness, friability, disintegration, dissolution, uniformity of dosage units (mass, content), particulate contamination (visible and sub-visible particles). | pH, refractometry, refractive index, optical rotation, viscosity, melting point, distilling range, loss on drying, water content, osmolarity, conductivity, heavy metals, residual solvents, limit tests, acid value, iodine value, peroxide value, ester value, hydroxyl value, saponification value. |
| Stability testing | ICH conditions (long term and accelerated conditions) Ongoing Stability Studies). | n/a |