SF - Quality Control Labs
Laboratory Details
Direcção da Comprovação da Qualidade (DCQ, Quality Control Division), Edifício Tomé Pires, Parque da Saúde de Lisboa, Avenue Brasil No 53
Lisboa,
1749-004
Portugal
Product Details
WHO Product ID
Portugal - INFARMED
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
INFARMED IP
Direcção da Comprovação da Qualidade (DCQ, Quality Control Division), Edifício Tomé Pires, Parque da Saúde de Lisboa, Avenue Brasil No 53
Lisboa,
1749-004
Portugal
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (UV-VIS, DAD, fluorescence, RI, ELS, MS, electrochemical detection), GC (FID, ECD, FPD, NPD, TCD, MS detection), TLC, UV-VIS spectrophotometry, flame photometry, AAS, FTIR, potentiometry, volumetric titrations, gravimetry | HPLC (UV-VIS, DAD, fluorescence, RI, ELS, MS, electrochemical detection), GC (FID, ECD, FPD, NPD, TCD, MS detection), TLC, UV-VIS spectrophotometry, flame photometry, AAS, FTIR, potentiometry, volumetric titrations, gravimetry |
| Identification | HPLC (UV-VIS, DAD, fluorescence, RI, ELS, MS, electrochemical detection), GC (FID, ECD, FPD, NPD, TCD, MS detection), capillary electrophoresis, TLC, UV-VIS spectrophotometry, FTIR, basic tests | HPLC (UV-VIS, DAD, fluorescence, RI, ELS, MS, electrochemical detection), GC (FID, ECD, FPD, NPD, TCD, MS detection), capillary electrophoresis, TLC, UV-VIS spectrophotometry, FTIR, basic tests |
| 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 |
| Physical/Chemical analysis | pH, density, optical rotation, viscosity, water content, conductivity, residual solvents, limit tests, tablet hardness, friability, disintegration, dissolution, uniformity of dosage units (mass, content) | pH, optical rotation, viscosity, melting point, loss on drying, water content, osmolarity, conductivity, residual solvents, sulphated ash, limit tests |