Optimized synthesis of suvorexant and determination of eight residual solvents by headspace gas chromatography.

ABSTRACT: This study presents an optimized synthetic pathway for suvorexant and establishes a robust method for the simultaneous determination of residual solvents. The synthesis commenced with chiral precursors, specifically (R)-3-(BOC-amino)butyric acid and N-benzyl glycine ethyl ester, employing a fragment splicing strategy. The target compound was synthesized through a sequence of nucleophilic reactions, BOC deprotection, cyclization, reduction, BOC protection, affinity substitution, and subsequent nucleophilic reactions, thereby circumventing the need for chiral separation. The post-treatment process was refined via recrystallization to yield the active pharmaceutical ingredient (API). For residual solvent analysis, a headspace gas chromatography (HS-GC) method was develope

SUBMITTER: Jia C 

PROVIDER: S-EPMC12573263 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature