Cyclophosphamide Impurity 3 (2HCl) es una impureza identificada en etapas de síntesis y formulación que se presenta como su sal dihidroclorurada y cuya presencia puede alterar el perfil de pureza del principio activo. Desde un punto de vista analítico muestra mayor polaridad frente al compuesto parental lo que influye en tiempos de retención por HPLC y en la ionización en espectrometría de masas. Su monitorización requiere métodos analíticos validados incluyendo HPLC con detección UV y confirmación por LC MS | establecimiento de límites de aceptación y estudios de degradación forzados para garantizar cumplimiento de especificaciones y requisitos regulatorios.
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To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
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