1500 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-albuterol (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Beschreibung
N-Nitroso-Salbutamol, auch als N-Nitroso-Albuterol oder Salbutamol Nitroso Impurity 1 bezeichnet, ist eine Nitrosamin-Verunreinigung aus dem Bereich der β2-Agonistenchemie und gilt als struktureller Warnhinweis für potenzielle Genotoxizität. Die Substanz besitzt die CAS-Nummer 2919946-71-5, die Summenformel C13H20N2O4 und eine molare Masse von 268,3 g/mol. Ihre Bildung kann durch nitrosierende Bedingungen an der sekundären Aminfunktion während Synthese, Lagerung oder bei Kontakt mit nitrithaltigen Hilfsstoffen erfolgen. Aufgrund der erwarteten Spurenkonzentrationen und des toxikologischen Risikos gemäß ICH M7 erfordert die Bestimmung üblicherweise selektive LC-MS/MS, ergänzt durch HRMS oder GC-MS.
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