3-[[2-[(2-Chloroethyl)amino]ethyl]amino]-1-propanol Dihydrogen Phosphate Dihydrochloride; Cyclophosphamide Impurity D Dihydrochloride; USP Cyclophosphamide Related Compound D;
Descripción
Impureza relacionada con ciclofosfamida designada Cyclophosphamide Related Compound D (CAS 158401-51-5) presentada como 3-[[2-[(2-Cloroetil)amino]etil]amino]-1-propanol dihidrogenofosfato dihidrocloruro | relevante por su formación durante síntesis | almacenamiento y procesos de conversión; requiere identificación y cuantificación precisa mediante HPLC | LC-MS y RMN para cumplimiento analítico y regulatorio. Su presencia puede indicar rutas de degradación por cloración o fosforilación incompletas | afectar perfiles de impurezas y dictar límites de aceptación en especificaciones de materia prima. Se recomienda control mediante optimización de condiciones de reacción | limpieza de procesos y estudios de estabilidad forzados para minimizar niveles y garantizar trazabilidad | reproducibilidad y seguridad del lote.
Referencias
Joqueviel, Claire, et al. Urinary Excretion of Cyclophosphamide in Humans, Determined by Phosphorus-31 Nuclear Magnetic Resonance Spectroscopy. Drug Metabolism and Disposition, vol. 26, no. 5, American Society for Pharmacology and Experimental Therapeutics, May 1998, pp. 418–28, dmd.aspetjournals.org/content/26/5/418.short. ?Fraiser, Lucy H., et al. Cyclophosphamide Toxicity. Drugs, vol. 42, no. 5, Nov. 1991, pp. 781–95, doi.org/10.2165/00003495-199142050-00005.?
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