SF - Quality Control Labs
Laboratory Details
40a Baitursynov street
Almaty,
50012
Kazakhstan
Product Details
WHO Product ID
Kazakhstan - NCEM Almaty
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
National Center for Expertise of Medicines, Medical Devices and Medical Equipment
40a Baitursynov street
Almaty,
50012
Kazakhstan
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | UV-VIS spectrophotometry TLC HPLC (UV, fixed wavelength, and DAD detection) | UV-VIS spectrophotometry TLC HPLC (UV, fixed wavelength, and DAD detection) |
| Identification | UV-VIS spectrophotometry TLC HPLC (UV, fixed wavelength, and DAD detection) | UV-VIS spectrophotometry TLC HPLC (UV, fixed wavelength, and DAD detection) |
| Physical/Chemical analysis | Clarity and degree of opalescence of liquids Degree of coloration of liquids pH Relative density Refractive index Optical rotation Loss on drying Osmolality Disintegration of tablets and capsules Dissolution test for solid dosage forms Uniformity of content of single dosage forms Uniformity of mass of single-dose preparation Friability of uncoated tablets Particulate contamination Visible particles Uniformity of dosage units UV-VIS spectrophotometry TLC HPLC (UV, fixed wavelength, and DAD detection) | Clarity and degree of opalescence of liquids Degree of coloration of liquids pH Relative density Refractive index Optical rotation Loss on drying Osmolality Particulate contamination Visible particles UV-Visible spectrophotometry TLC HPLC (UV, fixed wavelength, and DAD detection) |
| Microbiological Testing | Bacterial Endotoxins Tests (LAL test) | N/A |