Valaciclovir Nitroso Impurity 1 ist eine nitrosoabgeleitete, prozessbezogene Verunreinigung im Herstellungs- und Abbaubereich von Valaciclovir mit der Summenformel C5H4N6O2 und einer Molmasse von 180,1 g/mol. Die Struktur ist mit einer potenziellen Nitrosamin-Spezies vereinbar, einer Stoffklasse, die im Rahmen von ICH M7 und aktuellen Nitrosamin-Risikobewertungen wegen mutagener und genotoxischer Eigenschaften besonders kritisch bewertet wird. Die Bildung kann durch nitrosierende Bedingungen an aminhaltigen Vorstufen oder durch sekundäre Umwandlungen während der Lagerung erfolgen. Der Nachweis im Spurenbereich erfordert typischerweise LC-MS/MS, hochauflösende Massenspektrometrie und orthogonale chromatographische Verfahren.
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