Nilotinib Impurity 1 (HCl) é uma impureza relacionada identificada durante rotas sintéticas e estudos de degradação do nilotinibe | com relevância para o controle de qualidade e perfil de segurança do insumo. Caracteriza-se por comportamento cromatográfico distinto em HPLC e sinais específicos em espectrometria de massas e RMN que permitem a sua identificação e quantificação. Apresenta estabilidade afetada por pH e agentes oxidantes | exigindo condições analíticas robustas e validação conforme ICH Q2. A monitorização por métodos validados | estabelecimento de limites de especificação e investigação de origem são essenciais para reduzir riscos toxicológicos e garantir conformidade regulatória.
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