Process for the preparation of sorafenib tosylate
The present invention provides a process for the preparation of sorafenib tosylate, comprising contacting sorafenib free base with p-toluenesulphonic acid in water.
1. A process for the preparation of crystalline sorafenib tosylate of Formula I
by reacting sorafenib free base with p-toluenesulphonic acid in water, without using any other solvent.
2. The process according to claim 1 , wherein sorafenib free base obtained as a solution directly from a reaction in which the sorafenib free base is formed, is used as such without isolation.
3. The process according to claim 1 , wherein the sorafenib free base is contacted with 1 mole equivalent of p-toluenesulphonic acid.
4. The process according to claim 1 , wherein the sorafenib free base is contacted with 1.5 mole equivalents of p-toluenesulphonic acid.
5. The process according to claim 1 , wherein the sorafenib free base is contacted with more than 1 mole equivalent of p-toluenesulphonic acid.
6. The process according to claim 1 , wherein the sorafenib free base is contacted with p-toluenesulphonic acid at a temperature of 25° C. to 100° C.
7. The process according to claim 1 , wherein the sorafenib free base is contacted with p-toluenesulphonic acid for a period of 2 hours to 20 hours.
8. The process according to claim 1 , wherein a saturated solution of p-toluenesulphonic acid in water is used.