Cyclophosphamide Impurity 11 (CAS 2576-6-29) | também denominada 2-((2-chloroethyl)amino)ethan-1-ol | é uma impureza de baixo peso molecular relacionada ao composto precursor. Caracteriza-se por polaridade elevada e presença do grupo 2-cloroetil que confere reatividade e potencial formação de subprodutos. Pode originar-se por hidrólise e clivagem de ligações alquila durante síntese | purificação ou armazenamento. A sua identificação e quantificação requerem métodos analíticos sensíveis como LC-MS/MS | HPLC com detecção por ionização e espectroscopia de RMN para confirmação estrutural. Monitoramento | limites de especificação e estudos de estabilidade são essenciais para controle de qualidade e conformidade regulatória.
Referências
Kuz’menko, I. I., and L. B. Rapp. “Hydrolytic Cleavage of Diphenyl Di-(2-Chloroethyl)Amidophosphate.†Pharmaceutical Chemistry Journal, vol. 5, no. 5, May 1971, pp. 252–55, https://doi.org/10.1007/bf00771399.
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