SF - Quality Control Labs
Laboratory Details
Emil-Sommer-Strasse 7
Bremen,
D-28329
Germany
Product Details
WHO Product ID
Germany-InphA
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
InphA GmbH - Institute for Pharmaceutical and Applied Analytics
Emil-Sommer-Strasse 7
Bremen,
D-28329
Germany
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (DAD; UV-Vis, RI, conductivity, fluorescence, ELS, MS, charged aerosol, chemiluminescence, pulsed amperometric detection), GC (FID,MS), capillary electrophoresis, TLC, UV-Vis spectrophotometry, FTIR, AAS, AES, ICP/OES, electrophoresis, isoelectric focussing, volumetric titration (visual, potentiometric), gravimetry | HPLC (DAD; UV-Vis, RI, conductivity, fluorescence, ELS, MS, charged aerosol, chemiluminescence, pulsed amperometric detection), GC (FID,MS), capillary electrophoresis, TLC, UV-Vis spectrophotometry, FTIR, AAS, AES, ICP/OES, electrophoresis, isoelectric focussing, volumetric titration (visual, potentiometric), gravimetry |
| Identification | HPLC (DAD; UV-Vis, RI, conductivity, fluorescence, ELS, MS, charged aerosol, chemiluminescence, pulsed amperometric detection), GC (FID,MS), capillary electrophoresis, TLC, UV-Vis spectrophotometry, FTIR, AAS, AES, ICP/OES, electrophoresis, isoelectric focussing, basic tests | HPLC (DAD; UV-Vis, RI, conductivity, fluorescence, ELS, MS, charged aerosol, chemiluminescence, pulsed amperometric detection), GC (FID,MS), capillary electrophoresis, TLC, UV-Vis spectrophotometry, FTIR, AAS, AES, ICP/OES, electrophoresis, isoelectric focussing, basic tests |
| Microbiological Testing | Sterility test, microbial limit tests, bacterial endotoxins (LAL) | Sterility test, microbial limit tests, bacterial endotoxins (LAL) |
| Physical/Chemical analysis | pH, density, refractive index, optical rotation, osmolality, water content, residual solvents, limit tests, tablet hardness, friability, disintegration, dissolution, uniformity of dosage units (mass, content) | pH, density, refractive index, optical rotation, melting point, loss on drying, water content, residual solvents, sulphated ash, limit tests |