SF - Quality Control Labs
Laboratory Details
Conde Pereira Carneiro Street 80, Gameleira Neighbourhood
Belo Horizonte,
Minas Gerais
30510-030
Brazil
Product Details
WHO Product ID
Brazil - FUNED
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Ezequiel Dias Foundation (FUNED), Institute Octavio Magalhães, Medicines Service of Public Health Central Laboratory
Conde Pereira Carneiro Street 80, Gameleira Neighbourhood
Belo Horizonte,
Minas Gerais
30510-030
Brazil
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 detection), TLC, UV-VIS spectrophotometry, FTIR, volumetric titrations, potentiometry. Determination of related substances/ impurities, degradations products | HPLC (UV-VIS, DAD, fluorescence detection), TLC, UV-VIS spectrophotometry, FTIR, volumetric titrations, potentiometry. Determination of related substances/ impurities, degradations products |
| Identification | HPLC (UV-VIS, DAD, fluorescence detection), TLC, UV-VIS spectrophotometry, FTIR, basic tests | HPLC (UV-VIS, DAD, fluorescence detection), GC/MS, TLC, UV-VIS spectrophotometry, FTIR, basic tests |
| Microbiological Testing | Sterility test, microbial limit tests, bacterial endotoxins test (LAL) | Sterility test, microbial limit tests, bacterial endotoxins test (LAL) |
| Physical/Chemical analysis | pH, water content, loss on drying, density, disintegration, dissolution, friability, uniformity of dosage units (mass, content) | pH, water content, loss on drying, density |