Bupropion 3,5-Dichloro-Impurität, auch als 5-Chlorbupropion bezeichnet, ist eine halogenierte prozessbezogene Verunreinigung, die mit der Herstellung von Bupropionhydrochlorid und arylischen Chlorierungswegen verbunden ist, nicht mit einer eigenständigen pharmakologischen Klasse. Die Verbindung mit CAS 1193779-48-4 besitzt die Summenformel C13H17Cl2NO und eine Molekülmasse von 274,19 g/mol. Das chlorierte aromatische Motiv erhöht die chromatographische Retention und verändert die massenspektrometrische Fragmentierung, sodass für die Spurencharakterisierung LC-MS/MS oder hochauflösende LC-MS erforderlich sind, ergänzt durch HPLC-UV oder GC-MS als orthogonale Bestätigung, sofern die Flüchtigkeit dies zulässt. Regulatorisch wird sie im Rahmen der ICH-Impuritäts- und potenziellen mutagenen Risikobewertung betrachtet.
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