A impureza Cyclophosphamide Related Compound C (CAS 1071-28-9) representa um degradante estrutural associado ao processo de síntese e à estabilidade da ciclofosfamida | exigindo monitoramento rigoroso no controle de qualidade e no perfil de impurezas. Caracteriza-se por massa molecular e assinaturas espectrais que permitem identificação por HPLC com detecção UV | LC-MS e RMN para confirmação estrutural. Sua presença pode indicar condições de reação subótimas ou degradação durante armazenamento e impactar a pureza e a segurança do lote. Recomenda-se estabelecer limites de especificação baseados em ICH Q3A/B | validar métodos analíticos de rastreamento e implementar estratégias de controle de processo e estabilidade para mitigar sua formação e garantir conformidade regulatória.
Referências
Cho Youn-Ki, et al. “3-Aminopropyl Dihydrogen Phosphate (3-APPA; 3-Aminopropane Phosphoric Acid); a Novel Anti-Aging Substance.†Journal of Investigative Dermatology, vol. 4, no. 106, 2015, p. 895, www.infona.pl/resource/bwmeta1.element.elsevier-23c2ec19-b0bc-34b1-8dd3-54dce8db74e9.
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