Febuxostat is a urate lowering drug, an inhibitor of xanthine oxidase that is indicated for use in the treatment of hyperuricemia and chronic gout.
Specification :
Items |
Standards |
Results |
Appearance |
White to yellow crystalline powder |
White crystalline powder |
Solubility |
Freely soluble in DMF, soluble in THF, sparingly soluble in acetone, ethanol and ethyl acetate, slightly soluble in acetonitrile, very slightly soluble in methanol and practically insoluble in water |
Complies |
Identification |
HPLC/UV |
Complies |
Related Substances |
Total impurities:NMT1.0% Maximum single impurity:NMT0.5% |
0.20% 0.18% |
Loss on drying (Dry it at 105 in an electric air blowing dryer till a constant weight) |
NMT1.0% |
0.09% |
Residue on lgnition |
NMT0.1% |
0.07% |
Heavy Metal |
NMT20ppm |
Complies |
Chlorides |
NMT 0.04% |
Complies |
Assay(on dried basis) |
NLT 98.5% |
100.4% |
Packaging details:
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
Shelf Life: |
5 years if sealed and store away from direct sun light. |