Cyclophosphamide Impurity 11 (CAS 2576-6-29) | también conocida como 2-((2-Chloroethyl)amino)ethan-1-ol | es una impureza de degradación relevante en procesos de síntesis y almacenamiento de ciclofosfamida que puede afectar la calidad y seguridad del lote. Su monitorización requiere métodos analíticos sensibles como LC-MS o GC-MS con derivatización y HPLC validado según ICH Q3A/Q3B para establecer límites aceptables. Esta impureza puede formarse por hidrólisis parcial o reacciones de alcilación incompleta y su perfil de estabilidad influye en la definición de condiciones de purificación | control de proceso y estudios de estabilidad acelerada para asegurar cumplimiento regulatorio y reducción de riesgo en el producto final.
Referencias
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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