A impureza Bupropion Dihydro (R | RS)-Isomers (Maleate) caracteriza-se por um perfil estereoquímico complexo composto por isômeros R e RS resultantes de reações de redução durante a síntese ou degradação do princípio ativo. Esta impureza pode coeluir em métodos analíticos convencionais | exigindo metodologias cromatográficas quirais e validação por HPLC-MS e RMN para identificação e quantificação precisas. Sua presença influencia o perfil de pureza | estabilidade e especificações do lote | podendo interferir em ensaios de potência se não controlada. Estratégias de controle incluem otimização das etapas de purificação | limites de especificação baseados em ICH Q3A e monitoramento contínuo do perfil de impurezas.
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