Impureza C do Edoxaban (CAS 1255529-27-1) | também identificada como Edoxaban (SSS)-Isómero ou Edoxaban Impurity 2 | é um isómero crítico que exige caracterização detalhada do perfil químico e analítico. Sua elevada relevância para controle de qualidade farmacêutico decorre da necessidade de quantificação precisa por cromatografia líquida de alta eficiência e espectrometria de massas para determinação de pureza | ponto de ruptura e possíveis caminhos de degradação. Estudos de estabilidade | validação de método e avaliação de impurezas relacionadas são essenciais para estabelecer limites aceitáveis e garantir conformidade com requisitos regulatórios. Fornece dados fundamentais para investigação de síntese e otimização de processo.
Referências
Cuker, Adam, and Holleh Husseinzadeh. “Laboratory Measurement of the Anticoagulant Activity of Edoxaban: A Systematic Review.†Journal of Thrombosis and Thrombolysis, vol. 39, no. 3, Feb. 2015, pp. 288–94, https://doi.org/10.1007/s11239-015-1185-7. ‌Camm, A. John, and Henri Bounameaux. “Edoxaban.†Drugs, vol. 71, no. 12, Aug. 2011, pp. 1503–26, https://doi.org/10.2165/11595540-000000000-00000. ‌
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