Givinostat Impuriy 1, CAS 2485708-91-4, é uma impureza de प्रक्रिया, estruturalmente definida, associada ao inibidor da histona desacetilase givinostat. A fórmula molecular C24H25ClN2O3 e a massa molecular de 424.9 g/mol indicam um motivo amida aromática clorada, mais compatível com subproduto de síntese, arraste de intermediário ou conversão incompleta do que com degradação oxidativa simples. Impurezas desse tipo podem surgir em etapas de acilação, alquilação ou acoplamento e devem ser tratadas segundo os princípios de qualificação de impurezas, incluindo ICH Q3A e, quando houver preocupação genotóxica, ICH M7. A detecção normalmente requer LC-MS/MS ou LC-MS de alta resolução, com confirmação ortogonal por RMN e, quando necessário, LC-UV.
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