Nilotinib Hydrochloride Dihydrate and its Impurities

Nilotinib Hydrochloride Dihydrate is used to treat Philadelphia chromosome positive chronic myelogenous leukaemia. It is sold under the brand name Tasigna. Reference standards of Nilotinib Hydrochloride Dihydrate API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.