1500 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-bumetanide (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Beschreibung
Bumetanid-Nitroso-Verunreinigung, auch als N-Nitroso-Bumetanid bezeichnet, CAS 2490432-02-3, ist ein Nitrosamin-Derivat des Schleifendiuretikums Bumetanid. Mit der Summenformel C17H19N3O6S und einer Molekülmasse von 393,41 g/mol enthält die Verbindung ein N-Nitrosoalkylamino-Motiv, das mit potenziellem mutagenem Risiko assoziiert ist. Solche Spezies können durch nitrosative Degradation oder durch Reaktion sekundärer Aminvorstufen mit nitrosierenden Agenzien unter Prozess- oder Lagerbedingungen entstehen. Im regulatorischen Kontext werden Nitrosamine wegen ihrer Genotoxizitäts-Besorgnis unter ICH M7 und verwandten Leitlinien bewertet. Für Strukturbeweis und Spurenquantifizierung sind typischerweise LC-MS/MS, hochauflösende LC-MS und gegebenenfalls GC-MS nach Derivatisierung erforderlich.
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