Patent ID: 8217061

Claim:
A process for preparing crystalline Sorafenib tosylate characterized by a PXRD pattern having the peaks selected from the list consisting of: 7.7, 8.5, 9.8, 10.6, 12.0, 12.3, 12.9, 13.4, 13.5, 15.4 and 16.0, 16.5, 16.9, 17.3, 17.8, 18.7, 18.8, 19.3, 19.9, 20.3, 20.8, 21.2, 21.6, 22.5, 23.0, 23.4, 24.2, 24.5, 24.8, 25.2, 25.9, 26.9, 27.5, 27.7, 28.2, 29.2, 29.4, 29.8, 30.3, 31.4, 32.2, 33.5, 34.0, 35.2, 36.1, 37.2, and 37.7±0.2 degrees 2 theta, said process comprising a) combining Sorafenib tosylate, p-toluenesulfonic acid (PTSA) and a solvent selected from a group consisting of methanol, a mixture of methanol and N-methyl pyrrolidone (NMP), and a mixture of methanol and dimethylsulfoxide (DMSO), to obtain a suspension comprising Sorafenib tosylate methanol solvate; b) recovering crystalline Sorafenib tosylate methanol solvate from the suspension; and c) drying the crystalline Sorafenib tosylate methanol solvate at a temperature greater than room temperature to obtain crystalline Sorafenib tosylate.