Dihydroxycyclophosphamide (CAS 90632-33-0) | también conocido como Didechlorodihydroxycyclophosphamide | es una impureza relacionada que puede aparecer como subproducto de síntesis o degradación de compuestos fosforamidatos. Su caracterización analítica requiere técnicas instrumentales avanzadas como HPLC con detección UV | LC-MS/MS y espectroscopía NMR para confirmar estructura y masa exacta. La presencia de esta impureza afecta el perfil de pureza y la estabilidad del lote | por lo que es crucial establecer límites de especificación | métodos de cuantificación validados y estrategias de eliminación en procesos de purificación. La monitorización sistemática facilita la gestión de calidad y cumplimiento regulatorio.
Referencias
«Gurtoo, H. L., et al. “Effects of the Induction of Hepatic Microsomal Metabolism on the Toxicity of Cyclophosphamide.†British Journal of Cancer, vol. 51, no. 1, Jan. 1985, pp. 67–75, https://doi.org/10.1038/bjc.1985.10.?Clarke, Lynn, and David J. Waxman. “Oxidative Metabolism of Cyclophosphamide: Identification of the Hepatic Monooxygenase Catalysts of Drug Activation.†Cancer Research, vol. 49, no. 9, American Association for Cancer Research, May 1989, pp. 2344–50, cancerres.aacrjournals.org/c
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