发明名称 |
PROCESS FOR PREPARING CRYSTALLINE SORAFENIB TOSYLATE |
摘要 |
The present invention provides an industrially suitable process for the preparation of substantially pure 4-{4-[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]phenoxy}-N-methylpyridine-2-carboxamide or Sorafenib and its tosylate salt, with a suitable impurity profile and without requirement of any additional purification steps. The present invention also provides Sorafenib base (II) as stable crystalline Form-SSB. The present invention further relates to a process for the preparation of crystalline Sorafenib tosylate Form-I which is free from contamination of any other polymorphic form of Sorafenib tosylate, for e.g. Form II or Form III, and does not involve any seeding requirement for crystallization step. |
申请公布号 |
EP2922820(A1) |
申请公布日期 |
2015.09.30 |
申请号 |
EP20120877327 |
申请日期 |
2012.12.31 |
申请人 |
SHILPA MEDICARE LIMITED |
发明人 |
PUROHIT, PRASHANT;SPIRAM, RAMPALI;MOHANRAO, SESHAGIRI VIJAYA MURALI;LAVKUMAR, UPALLA |
分类号 |
C07D213/81;A61K31/44;A61P35/00 |
主分类号 |
C07D213/81 |
代理机构 |
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