PURIFIED TRAZODONE AND TRAZODONE HYDROCHLORIDE

摘要

PROBLEM TO BE SOLVED: To provide a trazodone containing, in the final product, less than 15 ppm of an alkylation substance which is used in the course of synthesis and whose genetic toxicity is proved or being suspended and a method of purifying trazodone hydrochloride.SOLUTION: A method of purifying trazodone or trazodone hydrochloride includes (a) a step of preparing an organic phase containing trazodone in at least one organic solvent, (b) a step of preparing a water phase containing at least one basic compound, (c) a step of mixing the water phase with the organic phase, (d) a step of heating at 40°C or higher for at least 30 min and (e) a step of recovering trazodone and optionally includes (f) a step of treating trazodone with hydrochloric acid to obtain trazodone hydrochloride. Trazodone and trazodone hydrochloride containing an alkylation substance in a content of less than 15 ppm and a medicinal composition containing the trazodone hydrochloride are also provided.