3-Amino-1-Propanol; Cyclophosphamide USP Related Compound E; 1-Amino-3-hydroxypropane;3-Propanolamine;beta-Alaninol;N-(3-Hydroxypropyl)amine;Dexpanthenol EP Impurity A;
Descripción
La Impureza EP G de ciclofosfamida corresponde a 3-amino-1-propanol, CAS 156-87-6, fórmula molecular C3H9NO y peso molecular 75.11 g/mol. Este alcanolamina es una impureza polar de bajo peso molecular relacionada con el proceso, asociada con la fabricación de ciclofosfamida o con la fragmentación hidrolítica de intermedios aminoalquílicos. Aunque no es una nitrosamina, su presencia es relevante en el perfil de impurezas porque puede originar artefactos de derivatización y señalar un control incompleto de etapas de aminación o de materias primas con contenido alcohólico. Su determinación a nivel traza suele requerir GC-MS o LC-MS/MS, con frecuencia tras derivatización previa a la columna para mejorar retención, ionización y selectividad.
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