Apixaban Related Compound 4 | também referida como Apixaban Impurity 74 e identificada pelo CAS 99585-01-0 | é um impurificante clorado do tipo 5-clorohexanoyl chloride que surge como subproduto em etapas de acilação do processo de síntese de apixaban. Trata-se de um cloreto de ácido altamente reativo e sensível à hidrólise | exigindo manuseio em condições anidras e temperatura controlada para evitar degradação e reações secundárias. A sua caracterização analítica recomenda LC-MS | HPLC com método validado | RMN e espectrometria de massa para quantificação e identificação estrutural. Considerações regulatórias incluem avaliação de níveis conforme ICH Q3A/Q3B e controle de segurança por ser corrosivo e acilante.
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