SF - Quality Control Labs
Laboratory Details
Br Artigas 3223
Montevideo,
11800
Uruguay
Product Details
WHO Product ID
Uruguay-CCCM
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Drug Quality Control Commission / Comisión para el Control de Calidad de Medicamentos (CCCM)
Br Artigas 3223
Montevideo,
11800
Uruguay
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 detection), TLC, UV-VIS spectrophotometry, FTIR, AAS/AES, volumetric titrations, potentiometry, polarimetry. Determination of related substances/ impurities, degradations products | HPLC (UV-VIS, DAD, fluorescence, RI detection), TLC, UV-VIS spectrophotometry, FTIR, AAS/AES, volumetric titrations, potentiometry, polarimetry. Determination of related substances/ impurities, degradations products |
| Physical/Chemical analysis | pH, water content, loss on drying, density, neutralizing capacity, dimensions, disintegration, dissolution, uniformity of dosage units (mass, content) | pH, water content, loss on drying, melting point, density, neutralizing capacity |
| 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, DAD, fluorescence, RI detection), TLC, UV-VIS spectrophotometry, FTIR, AAS/EA, basic tests | HPLC (UV-VIS, DAD, fluorescence, RI detection), TLC, spectroscopy (UV-VIS, FTIR, AA/EA), basic tests |