SF - Quality Control Labs
Laboratory Details
Ksaverska cesta 4
Zagreb,
10000
Croatia
Product Details
WHO Product ID
Croatia - HALMED OMCL
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Official Medicines Control Laboratory Division (OMCL Division) of the Agency for medicinal products and medical devices
Ksaverska cesta 4
Zagreb,
10000
Croatia
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC, TLC (semiquantitative), GC, UV-Vis, Optical rotation | HPLC, TLC (semiquantitative), GC, UV-Vis, Optical rotation |
| Identification | TLC, GC, UV-Vis, FTIR, NIR | TLC, GC, UV-Vis, FTIR, NIR |
| Microbiological Testing | Sterility, microbial purity, bacterial endotoxins test (LAL), pyrogens | Sterility, microbial purity, bacterial endotoxins test (LAL), pyrogens |
| Physical/Chemical analysis | Appearance, clarity and degree of opalescence of liquids, degree of coloration of liquids, test for extractable volume of parenteral solution, potentiometric determination of pH, conductivity, refractive index, relative density, loss on drying, loss on drying (vacuum), determination of nitrogen by sulphuric acid, optical rotation, viscosity, water content: semi-micro determination, water content: micro determination, particulate contamination: visible particles, optical rotation, osmolality, Disintegration (tablets, capsules, suppositories, pessaries), Dissolution, Hardness (resistance to crushing), Uniformity of Dosage Units. | Appearance, clarity and degree of opalescence of liquids, degree of coloration of liquids, test for extractable volume of parenteral solution, potentiometric determination of pH, conductivity, refractive index, relative density, loss on drying, loss on drying (vacuum), determination of nitrogen by sulphuric acid, optical rotation, viscosity, water content (semi-micro determination), water content (micro determination), particulate contamination (visible particles), optical rotation, osmolality. |