Identification, synthesis and strategy for minimization of potential impurities in the synthesis of suvorexant

Abstract

Eight process-related impurities in the synthesis of suvorexant were identified, while six of them were described for the first time. In order to get the references for the process optimization and quality control of API, the eight compounds were synthesized. According to the possible formation pathways, a modified synthesis and the strategy for impurity control in the corresponding reactions were established.