1500 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-moxifloxacin (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Beschreibung
N-Nitroso Moxifloxacin ist eine nitrosaminbezogene Verunreinigung, abgeleitet vom Fluorchinolon-Antibiotikum Moxifloxacin, mit N-Nitrosierung am piperazinischen Stickstoff. Mit der Summenformel C21H23FN4O5 und einer molaren Masse von 430,43 g/mol besitzt die Verbindung direkte Relevanz für regulatorische Bewertungen potenziell mutagener Verunreinigungen gemäß ICH-M7. Die Bildung kann durch Kontakt eines aminischen Vorläufers mit nitrosierenden Reagenzien während Synthese, Lagerung oder durch Wechselwirkungen mit Hilfsstoffen erfolgen. Aufgrund der erwarteten Spurenkonzentrationen erfordert die Bestimmung üblicherweise LC-MS/MS, hochauflösende Massenspektrometrie oder gekoppelte LC-UV-Verfahren mit hoher Selektivität.
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