Cyclophosphamide Related Compound C (CAS 1071-28-9) es una impureza relacionada con la síntesis y degradación de ciclofosfamida que puede formarse por reacciones secundarias durante la fabricación o por hidrólisis en condiciones de almacenamiento inadecuadas. Su identificación y cuantificación se realizan típicamente mediante HPLC acoplada a espectrometría de masas y confirmación por RMN | estableciéndose límites en el perfil de impurezas según guías ICH. La presencia de esta impureza afecta la pureza del lote y requiere control de proceso | monitoreo analítico riguroso y criterios de aceptación específicos en especificaciones de calidad para garantizar la seguridad y consistencia del producto final.
Referencias
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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