Losartan Impurity 6 é uma impureza processual relevante detectada durante o desenvolvimento e estabilidade do princípio ativo losartana. Caracteriza-se por apresentar perfil cromatográfico e massa molecular compatíveis com produtos de degradação ou reações secundárias | exigindo quantificação por HPLC com detecção UV e confirmação estrutural por LC-MS e RMN. A monitorização é essencial para garantir conformidade com limites estabelecidos por ICH | e para definição de especificações | métodos de limpeza e controles de processo. Estudos de degradação forçada e testes de estabilidade ajudam a definir vias de formação | sua toxicidade potencial e critérios de aceitação | orientando ações corretivas no processo de fabricação.
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