Stable crystalline monohydrate of epirubicin hydrochloride and method of production

Abstract

The present invention relates to a stable crystalline monohydrate of epirubicin hydrochloride having water content in the range between 2.7% and 3.5% (w/w) and being devoid of residual solvents as well as to a corresponding method for its production. The method comprises: (a) adding at least a first solvent and at least a second solvent to epirubicin hydrochloride, wherein the first solvent is a linear or branched C4 to C5 alcohol, and the second solvent is a linear or branched C2 to C3 alcohol; (b) adjusting in the solution obtained the water content to an amount in the range between 7% and 12% (w/w); and (c) heating the mixture to a temperature of 70° C. to 90° C. in order to allow crystallization.

Dependencies are inferred from the claim text.