100 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-epinephrine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
N-Nitroso Epinephrin, CAS 3006789-99-4, ist ein Nitrosamin-Derivat von Epinephrin mit der Summenformel C9H12N2O4 und einer Molmasse von 212,20 g/mol. Als N-nitroso Catecholamin-Verunreinigung kann es unter nitrosierenden Bedingungen aus geeigneten Aminvorstufen oder über oxidative Nitrosierungswege in komplexen Wirkstoffmatrices entstehen. Die Nitrosamingruppe ordnet diese Spezies der genotoxischen Verunreinigungsklasse zu, die im Rahmen von ICH M7 zu bewerten ist. Für die Spurenbestimmung sind üblicherweise LC-MS/MS und, zur strukturellen Absicherung, hochauflösende Massenspektrometrie erforderlich; zudem sind Adsorption und Matrixeffekte analytisch zu kontrollieren.
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