SF - Quality Control Labs
Laboratory Details
7-2-1813/5/A Adjacent to Post Office, Industrial Estate, Sanath Nagar
Hyderabad,
Telangana
500018
India
Product Details
WHO Product ID
India - Sipra
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Sipra Labs Limited
7-2-1813/5/A Adjacent to Post Office, Industrial Estate, Sanath Nagar
Hyderabad,
Telangana
500018
India
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (UV-VIS, PDA, RI detection), GC, UV, AA, FTIR spectrophotometry, Volumetric titrations, Potentiometric titration. | HPLC (UV-VIS, RI detection), GC, UV, AA, FTIR spectrophotometry, Volumetric titrations, Potentiometric titration. |
| Identification | IR, HPLC (UV-Visible, PDA, RI detection, Electro chemical), TLC, AA Spectrophotometry, Basic tests, GC (FID, TCD), UV-Vis Spectrophotometry. | IR, HPLC (UV-Visible, PDA, RI detection, Electro chemical), TLC, AA Spectrophotometry, Basic tests, GC (FID, TCD), UV-Vis Spectrophotometry, Chemical reaction, FT-IR, GC/MS, LC/MS, CHNS Analysis. |
| Microbiological Testing | Sterility test, Identification, Microbial limit tests, Microbial purity, Bacterial endotoxins test (LAL), Microbial assay, Preservative effectiveness test, Pyrogens. | Sterility test, Identification, Microbial limit tests, Microbial purity, Bacterial endotoxins test (LAL), Microbial assay, Preservative effectiveness test, Pyrogens. |
| Physical/Chemical analysis | pH, Density, Viscosity, Conductivity, Water content (Karl Fischer), Loss on drying, Refractive Index, Specific optical rotation, Limit tests, Residual solvents, Dimensions, Uniformity of dosage units (Mass, Content), Dissolution, Disintegration, Hardness, Friability, Nitrogen determination, Heavy metals, Osmolality, Particulate matter, Total organic carbon, Appearance, Extractable volume, Particle size, Re-dispersibility (Reconstitution time). | pH, Solubility, Water content, Melting point, Refractometry, Loss on drying, Limit tests, X- ray diffractometry, Thermal analysis (DSC, TGA), Optical rotation, Conductivity, Density, Specific gravity, Viscosity, Osmolarity, Heavy metals, Sulphated ash, Acid insoluble ash, Residual solvents, Nitrogen value, Osmolality, Particulate matter, Appearance, Clarity and Degree of opalescence of liquids, Degree of coloration of liquids, Distilling range, Acid value, Ester value, Hydroxyl value, Iodine value, Peroxide value, Saponification value, Total organic carbon, Particle size, Freezing point, Drop point, Boiling point, Unsaponifiable matter, Organic volatile impurities, ICP-MS, AA. |
| Stability testing | ICH Conditions | ICH Conditions |