Mizolastine Impurity 3 (Acetate Salt) | CAS 123018-79-1 | é uma impureza relacionada observada no processo sintético de mizolastina. Caracteriza-se como sal acetato que requer monitorização rigorosa no controlo de qualidade para atender a limites analíticos. A sua identificação e quantificação são realizadas por HPLC com detecção UV | LC-MS e confirmação por RMN quando necessário. Pode originar-se por acetilação parcial ou reações secundárias durante etapas de síntese e purificação | afetando perfil de pureza e estabilidade do API. Recomenda-se inclusão em métodos de perfil de impurezas | validação de recuperação e definição de limites de aceitação para garantir conformidade regulatória.
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