100 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N‑Nitrosophenylephrine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Beschreibung
N-Nitroso Phenylephrin (CAS 78658-64-7) ist eine Nitrosamin-Verunreinigung, die aus der sekundären Aminfunktion phenylephrinbezogener Strukturen hervorgeht und durch Nitrosierung, oxidativen Stress oder prozessbedingte Kontamination mit Nitritquellen entstehen kann. Mit der Formel C9H12N2O3 und einer Molekülmasse von 196,2 g/mol enthält die Verbindung eine N-Nitroso-Gruppe an einem chiralen Aminoalkohol-Gerüst, ein strukturelles Alarmsignal im Rahmen der Bewertung genotoxischer Verunreinigungen nach ICH M7. Die Spurenanalytik erfordert typischerweise hochselektive LC-MS/MS, ergänzt durch hochauflösende Massenspektrometrie oder GC-MS nach Derivatisierung.
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