Haloperidol Byproduct 5 é uma impureza relacionada ao processo de síntese e degradação do haloperidol | identificada por análises de LC-MS e confirmada por RMN. Caracteriza-se por massa molecular e perfil de fragmentação específicos e por coeluição variável em cromatografia HPLC | exigindo métodos validados para quantificação. A sua formação está associada a etapas de acoplagem e a condições oxidativas de armazenamento | podendo comprometer a pureza do lote e a conformidade com diretrizes ICH Q3A/Q3B. Estratégias de controle incluem otimização das condições de reação | controles de matéria-prima | testes de estabilidade forçados e limites analíticos definidos nas especificações de qualidade.
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