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;
Beschreibung
Cyclophosphamid EP-Impurität G entspricht 3-Amino-1-propanol, CAS 156-87-6, Summenformel C3H9NO, Molekulargewicht 75,11 g/mol. Dieses Alkanolamin ist eine polare, niedermolekulare prozessbedingte Verunreinigung, die mit der Herstellung von Cyclophosphamid oder mit hydrolytischer Fragmentierung aminoalkylischer Zwischenstufen in Zusammenhang stehen kann. Obwohl es sich nicht um ein Nitrosamin handelt, ist sein Nachweis im Impuritätsprofil bedeutsam, da es Derivatisierungsartefakte beeinflussen und auf unvollständige Kontrolle von Aminierungsschritten oder alkoholhaltigen Ausgangsstoffen hinweisen kann. Die Spurenbestimmung erfordert typischerweise GC-MS oder LC-MS/MS, häufig nach Vorkolonnenderivatisierung zur Verbesserung von Retention, Ionisation und Selektivität.
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