Amlodipin-Mannitol-Addukt ist eine definierte prozessbezogene Verunreinigung des Dihydropyridin-Calciumkanalblockers Amlodipin in Verbindung mit dem Polyol Mannitol. Mit der Summenformel C26H37ClN2O10 und einer Molmasse von 573,04 g/mol ist es mit einer kovalenten Adduktbildung während Herstellung oder Lagerung unter Bedingungen vereinbar, die karbonylvermittelte oder dehydratisierungsbegünstigte Kopplung erlauben. Die Substanz ist weder ein einfacher Abbauprodukt noch eine klassische genotoxische Verunreinigung, kann jedoch auf Wechselwirkungen in der Formulierung hinweisen. Die Charakterisierung erfordert typischerweise LC-MS/MS zur Massenbestätigung sowie ergänzend hochauflösende LC-HRMS und orthogonale HPLC-UV- oder NMR-Methoden bei isolierbarem Material.
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