SF - Quality Control Labs
Laboratory Details
CP 14050, Calzada de Tlalpan No. 4492, Colonia Toriello Guerra, Delegacion Tlalpan
Mexico City,
Mexico
Product Details
WHO Product ID
Mexico - CCAYAC
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Commission of Analytical Control and Coverage Extension (CCAYAC)
CP 14050, Calzada de Tlalpan No. 4492, Colonia Toriello Guerra, Delegacion Tlalpan
Mexico City,
Mexico
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, AAS/AES, volumetric titrations | HPLC (UV-Vis, DAD fluorescence detection), TLC, UV-VIS spectrophotometry, volumetric titrations |
| Identification | HPLC (UV-VIS, DAD, fluorescence detection), TLC, UV-VIS spectrophotometry, FTIR | HPLC (UV-VIS, DAD, fluorescence, detection), TLC, UV-VIS spectrophotometry, FTIR |
| Physical/Chemical analysis | pH, water content (Karl Fischer), loss on drying, dissolution, uniformity of dosage units (mass, content) | pH, water content, loss on drying |
| 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 |