Mizolastine Impurity 9 (CAS 935860-13-2) é uma impureza crítica identificada no perfil de estabilidade e no controle de qualidade do processo sintético. Sua caracterização estrutural por LC-MS | HPLC e RMN permitiu esclarecer sua origem como produto secundário de rearranjo ou de reação lateral | influenciada por condições ácidas e temperaturas elevadas. Estudos de avaliação quantitativa definem limites aceitáveis conforme diretrizes ICH Q3A e suportam estratégias de mitigação que incluem otimização de etapas reativas | purificação por cromatografia preparativa e validação de métodos analíticos seletivos. Fornece informações essenciais para a gestão do perfil de impurezas e para a conformidade regulatória.
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