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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. |
