Patent ID: 7732601

Claim:
A process for the preparation of the α-crystal form of the methanesulfonic acid addition salt of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-[4-pyridin-3-yl)pyrimidin-2-ylamino]phenyl]benzamide comprising: a) carrying out an acid addition reaction using not more than 0.99 equivalents of methanesulfonic acid per 1 equivalent of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-[(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]benzamide, in a solvent selected from the group consisting of C 2 -C 6 aliphatic alcohols and the mixtures thereof, optionally with the addition of a C 1 -C 4 aliphatic alcohol; b) optionally adding a solvent selected from the group consisting of esters formed from a C 1 -C 4 aliphatic alcohol and formic acid, acetic acid, or propionic acid; c) optionally inoculating the reaction mixture with the α-crystal form; d) stirring the reaction mixture for the time necessary for crystallization of the α-crystal form; and e) isolating the α-crystal form from the reaction mixture, wherein said α-crystal form of the methanesulfonic acid addition salt of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-[(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]benzamide isolated from the reaction mixture shows an X-ray powder diffraction pattern that is characterized by having peaks at 2θ angles of approximately: 4.9; 18.6; 19.1; 23.2 and 28.6°.