Norfenfluramine composition and its preparation method

摘要

Methods for preparing fenfluramine active pharmaceutical ingredients are provided. Aspects of the method include (a) hydrolyzing a 2- (3- (trifluoromethyl) phenyl) acetonitrile composition to produce a 2- (3- (trifluoromethyl) phenyl) acetic acid composition; (B) reacting a 2- (3- (trifluoromethyl) phenyl) acetic acid composition with acetic anhydride and a catalyst to produce a 1- (3- (trifluoromethyl) phenyl) propan-2-one composition And (c) reductive amination of the 1- (3- (trifluoromethyl) phenyl) propan-2-one composition with ethylamine using a borohydride reducing agent to produce a fenfluramine composition Including stages. Similarly provided are compositions and pharmaceutical ingredients prepared according to this method comprising a pharmaceutically acceptable salt of fenfluramine and having a total of less than 0.2% by weight of trifluoromethyl regioisomers.