Crystallization of epidaunorubicin x HCl

摘要

The present invention relates to a form of crystalline epidaunorubicin hydrochloride which is stable and readily soluble, and to a process for the production thereof. This process comprises crystallizing epidaunorubicin hydrochloride in a solvent system including (a) solvent A which is selected from the group consisting of C1 and C2 halogenated solvents and mixtures thereof, (b) solvent B which is selected from the group consisting of C1 - C5 straight and branched alcohols and mixtures thereof, and (c)solvent C which is selected from the group consisting of C1 - C5 straight and branched alcohols and mixtures thereof, wherein solvent C is selected to provide lower solubility to epidaunorubicin hydrochloride than solvent B.