发明申请
US20150112085A1 PURE CRYSTALLINE FORM II OF L-MALIC ACID SALT OF SUNITINIB AND PROCESSES FOR ITS PREPARATION 有权
堇青霉素的L-马来酸盐的纯晶体形式II及其制备方法

PURE CRYSTALLINE FORM II OF L-MALIC ACID SALT OF SUNITINIB AND PROCESSES FOR ITS PREPARATION
摘要:
The present invention relates to pure crystalline Form II of an L-malic acid salt of sunitinib and a process for its preparation. The invention further provides crystalline Form II of an L-malic acid salt of sunitinib having a purity of at least 97.0%. The invention also provides crystalline Form II of an L-malic acid salt of sunitinib substantially free of an anti-oxidant. The invention also provides crystalline Form II of L-malic acid salt of sunitinib which remains chemically pure on storage at 25° C.±2° C. and 40° C.±2° C. at a relative humidity of 60%±5% and 75%±5%, respectively, for at least 1 month.
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