Patent ID: 8686164

Claim:
A process for producing crystalline 4â€²-epidaunorubicin hydrochloride comprising crystallizing 4â€²-epidaunorubicin hydrochloride in a solvent system including: a) solvent A which is selected from the group consisting of C 1 and C 2 halogenated solvents and mixtures thereof; b) solvent B which is selected from the group consisting of C 1 -C 5 straight and branched alcohols and mixtures thereof; and c) solvent C which is selected from the group consisting of C 1 -C 5 straight and branched alcohols and mixtures thereof, wherein solvent C is selected to provide lower solubility to 4â€²-epidaunorubicin hydrochloride than solvent B, wherein the process comprises steps of: dissolving 4â€²-epidaunorubicin hydrochloride in a solvent mixture I comprising (i) solvent A and (ii) solvent B or C to form a solution; and contacting the solution with a solvent mixture II comprising solvents B and C.