Bilastin-Nitroso-Verunreinigung 1, auch als N-Nitroso-Bilastin bezeichnet, ist eine nitrosaminbezogene Prozess- oder Abbauverunreinigung, die aus der Nitrosierung einer sekundären Aminfunktion hervorgeht. Die CAS-Nummer lautet 2731008-04-9; die Zusammensetzung C12H14N4O entspricht einer Molekülmasse von 230,3 g/mol. Als strukturelles Nitrosamin ist sie im Rahmen der Genotoxizitätsbewertung nach ICH M7 relevant, da N-Nitroso-Spezies potenziell DNA-reaktiv sind. Der Nachweis im Spurenbereich erfordert in der Regel hochsensitive orthogonale Verfahren, insbesondere LC-MS/MS, ergänzt durch LC-HRMS zur Strukturabsicherung und, sofern die Flüchtigkeit ausreicht, GC-MS.
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