| abstract |
The present invention provides a purified form of trazodone and trazodone hydrochloride represented by the following formula, which contains less than 15 ppm of an alkylated substance with proven or suspected genotoxicity. (A) preparing an organic phase containing trazodone in at least one organic solvent; (b) preparing an aqueous phase containing at least one basic compound; (c) A step of mixing an aqueous phase and the organic phase, (d) a step of heating at a temperature of 40 ° C. or higher for at least 30 minutes, and (e) a step of recovering the trazodone, optionally (f) A process for producing trazodone or trazodone hydrochloride comprising a step of treating trazodone with hydrochloric acid to obtain trazodone hydrochloride. Trazodone or trazodone hydrochloride containing less than 15 ppm of an alkylating substance, and a pharmaceutical composition comprising the trazodone hydrochloride. [Selection figure] None |