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, Spectrophotometry (UV-Vis and FTIR), AAS/AES and Volumetric titration. | HPLC (UV-Vis, DAD, fluorescence detection), TLC, Spectrophotometry (UV-Vis and FTIR), AAS/AES and Volumetric titration. |
| Identification | HPLC (UV-Vis, DAD, fluorescence detection), TLC, Spectrophotometry (UV-Vis and FTIR). | HPLC (UV-Vis, DAD, fluorescence detection), TLC, Spectrophotometry (UV-Vis and FTIR). |
| Microbiological Testing | Sterility Test, Microbiological Assay of antibiotics, Microbial Limit Test, Bacterial Endotoxin Testing (Endotoxin Test {LAL}) | Sterility Test, Microbiological Assay of antibiotics, Microbial Limit Test, Bacterial Endotoxin Testing (Endotoxin Test {LAL}) |
| Physical/Chemical analysis | pH, Loss on Drying, Water Content (Karl Fischer), Dissolution, Uniformity of Dosage Units. | pH, Loss on Drying, Water Content |