CRYSTALLINE AMRUBICIN HYDROCHLORIDE

PROBLEM TO BE SOLVED: To obtain the subject compound exhibiting a specific powder X-ray diffraction pattern, having excellent storage stability and useful as a medicine. SOLUTION: This crystalline amrubicin hydrochloride exhibits a powder X-ray diffraction pattern comprising diffraction angles 2 θ and relative strengths expressed in the table. The compound is obtained, for example, by adding (B) a hydrophilic organic solvent preferably such as acetone to (A) the aqueous or water-containing organic solvent (for example, preferably an acetone-water mixture solvent) of amrubicin hydrochloride, for example, for 10 min to 1 day preferably at 22-40 deg.C and subsequently crystallizing the amrubicin hydrochloride preferably for about 1-5 hr. The component A is preferably mixed with an acid such as acetic acid to control the pH of the solution to 1.5-4. The solvent in the component A is preferably used in an amount of 10-30 times weight that of the amrubicin hydrochloride, and the component B is also preferably used in an amount of 10-20 times weight that of the component A.