SF - Quality Control Labs
Laboratory Details
Medicines Control Laboratory, Stevinstraat 137
Brussels,
1000
Belgium
Product Details
WHO Product ID
Belgium - SCM DGO
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Association Pharmaceutique Belge - SCM-DGO
Medicines Control Laboratory, Stevinstraat 137
Brussels,
1000
Belgium
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | (U)HPLC (UV-Vis, DAD, RI, Fluorescence, ELSD, MS), GC (FID), (HP)TLC, UV-Vis, FTIR, AAS/AES, titrations, determination of related substances/impurities, degradation products and residual solvents, nitrogen determination | (U)HPLC (UV-Vis, DAD, RI, Fluorescence, ELSD, MS), GC (FID), (HP)TLC, UV-Vis, FTIR, AAS/AES, titrations, determination of related substances/impurities, degradation products and residual solvents, oxygen flask combustion, nitrogen determination |
| Identification | (U)HPLC (UV-Vis, DAD, RI, Fluorescence, ELSD, MS), GC(FID), (HP)TLC, UV-Vis, FTIR, AAS/AES, basic tests | (U)HPLC (UV-Vis, DAD, RI, Fluorescence, ELSD, MS), GC (FID), (HP)TLC, UV-Vis, FTIR, AAS/AES, basic tests |
| Microbiological Testing | Sterility test, microbiological, examination of non-sterile products, bacterial endotoxins test (LAL), microbial assay of antibiotics, ELISA, preservative challenge test | Sterility test, microbiological examination of non-sterile products, bacterial endotoxins test (LAL), microbial assay of antibiotics, ELISA, preservative challenge test |
| Physical/Chemical analysis | pH, water content, loss on drying, friability, tablet hardness melting point, optical rotation, refractive index, disintegration time, dissolution, density, viscosity, osmolality, conductivity, uniformity of dosage units (mass, content), uniformity of delivered dose of (non)pressurized MDI, residual solvents, limit tests. | pH, water content, loss on drying, , refractive index, optical rotation, viscosity, melting point, residue on ignition, conductivity, heavy metals, residual solvents, limit tests, acid value, iodine value, peroxide value, ester value, hydroxyl value, saponification value |