Salbutamol Impurity 111 é uma impureza identificada no perfil do princípio ativo do salbutamol | relevante para controle de qualidade e avaliação de risco. Caracteriza-se por presença em níveis traço resultantes de vias de degradação como oxidação ou clivagem térmica da cadeia lateral. A identificação e quantificação exigem técnicas analíticas sensíveis como HPLC com detecção por UV e LC-MS/MS para confirmação de massa e estrutura. Deve ser monitorada conforme diretrizes ICH Q3A/Q3B com limites de especificação baseados em avaliação toxicológica. Estratégias de controle incluem otimização do processo | etapas de purificação | adição de estabilizantes e validação de métodos analíticos com padrão de referência apropriado.
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