Carboxyphosphamide (CAS 22788-18-7) | conocido también como Cyclophosphamide Impurity 25 | es una impureza asociada a la síntesis y degradación del ciclofosfamida; su control es crítico en desarrollo farmacéutico. Presenta un perfil físico-químico que requiere análisis por HPLC/UPLC y confirmación por LC-MS y RMN para caracterización estructural | además de espectroscopía IR y análisis elemental cuando proceda. Se recomienda especificar límites y criterios de aceptación basados en evaluación de riesgo | incluir estudios de estabilidad y validación analítica conforme a directrices ICH sobre impurezas. Se suministra con ficha técnica y datos analíticos para asegurar integridad del perfil de impurezas.
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