Nilotinib Impurity 28 (CAS 1807607-72-2) é uma impureza relacionada ao nilotinibe encontrada durante síntese e estabilidade. Sua caracterização é crítica para garantir qualidade e segurança da substância ativa | exigindo identificação estrutural por LC-MS/HRMS e confirmação por RMN. A detecção e quantificação são realizadas tipicamente por HPLC-UV e LC-MS/MS com padronização por padrão de referência. Estudos de perfil de impurezas e degradação ajudam a esclarecer vias de formação e condições de armazenamento que promovem sua geração. Controle e qualificação seguem diretrizes regulatórias aplicáveis como ICH Q3A | com limites estabelecidos conforme risco toxicológico e perfil farmacêutico.
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