Sorafenib dimethyl sulphoxide solvate

Sorafenib dimethyl sulphoxide solvate of Formula III characterized by X-ray diffraction pattern as depicted in FIG. 1.

Sorafenib dimethyl sulphoxide solvate of Formula III characterized by DSC thermogram having endotherms at about 123.69° C. and about 202.54° C.

Sorafenib dimethyl sulphoxide solvate of Formula III characterized by DSC thermogram as depicted in FIG. 2.

Sorafenib dimethyl sulphoxide solvate of Formula III characterized by X-ray diffraction pattern as depicted in FIG. 1 and DSC thermogram as depicted in FIG. 2.

Sorafenib dimethyl sulphoxide solvate of Formula III characterized by TGA as depicted in FIG. 3.

Sorafenib dimethyl sulphoxide solvate of Formula III characterized by IR spectrum as depicted in FIG. 4.

Sorafenib dimethyl sulphoxide solvate of Formula III having purity greater than 99% by HPLC.

A process for the preparation of sorafenib dimethyl sulphoxide solvate of Formula III

• comprising contacting sorafenib free base of Formula I
• with dimethyl sulphoxide.

A process for the preparation of sorafenib free base of Formula I

• comprising contacting sorafenib dimethyl sulphoxide solvate of Formula III
• with a solvent.

A process for the preparation of sorafenib free base of Formula I

• comprising heating sorafenib dimethyl sulphoxide solvate of Formula III
• above 110° C.

A process for the preparation of sorafenib acid addition salts of Formula IV

• comprising contacting sorafenib dimethyl sulphoxide solvate of Formula III with an acid of Formula HX and isolating sorafenib acid addition salt of Formula IV.

A pharmaceutical composition comprising sorafenib dimethyl sulphoxide solvate of Formula III and one or more pharmaceutically acceptable carriers, diluents or excipients.

Use of sorafenib dimethyl sulphoxide solvate of Formula III for the treatment of cancer.

An HPLC method for the identification, quantification and isolation of related substances of sorafenib or its pharmaceutically acceptable salts, comprising the use of a buffer and a single organic solvent as mobile phase.

Sorafenib tosylate of Formula II substantially free of 4-(2-(N-methylcarbamonyl)-4-(pyridyloxy)aniline.

Sorafenib tosylate of Formula II substantially free of 4-chloro-N-methyl-2-pyridinecarboxamide.

Sorafenib tosylate of Formula II substantially free of 4-chloro-3-(trifluoromethyl)phenyl isocyanate.