SUNITINIB MALATE N-(2-(Diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide (2S)-hydroxybutanedioate (Z)-N-(2-(diethylaMino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)Methyl)-2,4-diMethyl-1H-pyrrole-3-carboxaMide (S)-2-hydroxysuccinate
Item |
Specification |
Results |
Appearance |
Pale yellow to off-white powder |
Conforms |
Identification |
a) IR:IR chromatograph Conforms to the characteristic peak of R.S. |
Conforms |
b) HPLC :The retention time of the major peak in the chromatogram Conforms to the characteristic peak of R.S. |
Conforms |
|
Residue on ignition |
≤ 0.1% |
0.07% |
Loss on drying |
≤1.0% |
0.35% |
Heavy Metals |
≤20 ppm |
Conforms |
Related substance |
||
Single impurity |
≤0.50% |
0.22% |
Total impurities |
≤1.0% |
0.61% |
Assay[HPLC] |
≥99.0% |
99.53% |
Conclusion |
The results comply with standards of enterprise. |
Sunitinib malate is an oral, small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor. Sunitinib malate was approved by the FDA for the treatment of renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST) on January 26, 2006. Sunitinib malate was the first cancer drug simultaneously approved for two different indications.
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