N-Nitroso Aceclofenac ist das N-Nitrosamin-Derivat von Aceclofenac und eine strukturell definierte Verunreinigung mit toxikologischer Relevanz, die durch Nitrosierung des anilidischen Stickstoffs unter sauren, nitrithaltigen oder prozessbedingten Bedingungen entstehen kann. Mit der Summenformel C16H12Cl2N2O5 und einer Molmasse von 383,18 g/mol trägt es das charakteristische N-Nitroso-Motiv, das mit potenzieller Genotoxizität und der Bewertung nach ICH M7 sowie einschlägigen Nitrosamin-Risikokonzepten verbunden ist. Die Spurenbestimmung erfordert üblicherweise selektive LC-MS/MS oder hochauflösende LC-MS, ergänzend GC-MS bei geeigneter Flüchtigkeit und Chromatographie, da UV-Verfahren keine ausreichende Spezifität besitzen.
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