Acalabrutinib Impurity 13 (CAS 1420478-90-5) é uma impureza relacionada ao processo de síntese que requer caracterização rigorosa por representar um atributo crítico de qualidade. Detectada em níveis traço | sua identificação e quantificação são realizadas por métodos validados como HPLC/UHPLC acoplada a espectrometria de massas e confirmação estrutural por RMN e HRMS. Estudos de degradação forçada e perfil de estabilidade esclarecem sua origem e cinética. O estabelecimento de limites e critérios de aceitação conforme ICH Q3A e Q3B | além do desenvolvimento de métodos de controle específicos | é essencial para monitorar e mitigar riscos ao perfil de pureza do ingrediente farmacêutico.
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