Reduced Haloperidol (CAS 34104-67-1) | também referido como Hydroxyhaloperidol | é uma impureza redutiva crítica encontrada em lotes de haloperidol. Caracteriza-se por alteração do núcleo piperidínico com adição de hidroxila | impactando perfil farmacológico e estabilidade. Forma-se por processos de redução durante síntese ou armazenamento sob condições redutoras e pode coeluir com o composto mãe em cromatografia. Detectável por HPLC com detecção por UV e confirmável por LC-MS/MS e RMN | exigindo padrões de referência e métodos validados para quantificação. Controle exige otimização de etapas de síntese | condições de reação e testes de liberação conforme diretrizes regulatórias.
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