POLYMORPHIC FORM OF FINASTERIDE AND ITS PRODUCTION

摘要

17b-(N-tert-butylcarbamoyl)-4- aza - 5a-androst-1-en-3-one of the structure that exists in polymorphic Form I, characterized by characteristic absorption bands obtained from X-ray powder diffraction spectral d-spacings of 6.44, 5.69, 5.36, 4.89, 4.55, 4.31, 3.85, 3.59 and 3.14; a differential scanning calorimetry curve, at a heating rate of 20!C/min, that exhibits a minor endotherm with a peak termperature of about 232oC and an extrapolated onset temperature of about 223oC with an associated heat of about 11 joules/gm and that exhibits a major melting endotherm with a peak temperature of about 261oC and an extrapolated onset temperature of about 258oC with an associated heat of about 89 joules/gm; an FT-IR spectrum (in KBr) showing bands at 3431, 3237, 1692, 1666, 1602 and 688 cm-1; and solubilities in water and cyclohexante at 25oC of 0.05+0.02 and 0.27+0.05 mg/gm, respectively.