Processes for the preparation of highly pure Rivaroxaban crystal modification I

摘要

Provided herein are improved, commercially viable and consistently reproducible processes for the preparation of highly pure crystal Modification I of Rivaroxaban, which is free from other polymorphs and undesired solvated forms. Provided also herein is a highly pure and stable crystal Modification I of Rivaroxaban essentially free of other solid state forms.

主权项

1. A process for the preparation of Crystal Modification I of Rivaroxaban, comprising:
a) providing a solution of Rivaroxaban in a solvent medium comprising water and acetone at an ambient temperature; b) optionally, subjecting the solution obtained in step-(a) to carbon treatment to obtain a filtrate; c) cooling the solution obtained in step-(a) or step-(b) at a temperature of below about 35° C. to cause crystallization; and d) recovering highly pure crystal Modification I of Rivaroxaban formed in step-(c).