Crystallization of 4'-epidaunorubicin x hci

A process for producing crystalline 4′-epidaunorubicin hydrochloride comprising crystallizing 4′-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 4′-epidaunorubicin hydrochloride than solvent B.

Crystalline 4′-epidaunorubicin hydrochloride characterized by its powder X-ray diffraction pattern comprising the following characteristic peaks:

• Diffraction Angle 2 (theta)
• Relative intensity P (%)
• 5.13
• 40.00-46.00
• 7.64
• 29.00-33.50
• 12.18
• 23.50-26.00
• 16.77
• 18.90-20.70
• 17.00
• 24.50-26.90
• 19.86
• 54.00-62.00
• 21.82
• 25.80-28.25
• 22.58
• 100
• 23.03
• 30.00-32.00