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
- 专利标题: PURE CRYSTALLINE FORM II OF L-MALIC ACID SALT OF SUNITINIB AND PROCESSES FOR ITS PREPARATION
- 专利标题(中): 堇青霉素的L-马来酸盐的纯晶体形式II及其制备方法
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申请号: US14147757申请日: 2014-01-06
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公开(公告)号: US20150112085A1公开(公告)日: 2015-04-23
- 发明人: Hari Babu MATTA , Mahavir Singh KHANNA , Mohan PRASAD
- 申请人: Ranbaxy Laboratories Limited
- 申请人地址: IN New Delhi
- 专利权人: RANBAXY LABORATORIES LIMITED
- 当前专利权人: RANBAXY LABORATORIES LIMITED
- 当前专利权人地址: IN New Delhi
- 优先权: IN3112/DEL/2013 20131018
- 主分类号: C07D403/06
- IPC分类号: C07D403/06 ; C07C59/245
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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