SUBSTANTIALLY PURE IMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF

摘要

Provided herein are impurities of imatinib, N-(2-Methyl-5-methylamino-phenyl)-N-(4-pyridin-3-yl-pyrimidin-2-yl)-formamide (formamide impurity) and 4-[4-(Imidazole-1-carbonyl)-piperazin-1-ylmethyl]-N-[4-methyl-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-phenyl]-benzamide (carbonylimidazole impurity), and processes for the preparation and isolation thereof. Provided further herein is a highly pure imatinib or a pharmaceutically acceptable salt thereof substantially free of formamide and carbonylimidazole impurities, processes for the preparation thereof, and pharmaceutical compositions comprising highly pure imatinib or a pharmaceutically acceptable salt thereof substantially free of impurities. Disclosed also herein is a process for preparing substantially pureα-form of imatinib mesylate.