Roxadustat Impurity 3, auch als Roxadustat Aziridine Impurity bezeichnet, ist eine prozessbezogene heterozyklische Verunreinigung mit aziridinhaltigem, epoxidähnlichem Strukturmotiv und der CAS-Nummer 2301113-15-3. Mit der Summenformel C19H16N2O5 und einer Molekülmasse von 352.34 g/mol stellt sie ein strukturell eigenständiges Analogon des Wirkstoffs dar, der die Prolylhydroxylase des Hypoxie-induzierbaren Faktors hemmt. Der Aziridinring spricht für Entstehung während synthetischer Derivatisierung oder unvollständiger Ringöffnungssteuerung; wegen der potenziell elektrophilen Natur ist eine Bewertung im Rahmen der Verunreinigungsqualifizierung und genotoxikologischer Anforderungen relevant. Die Identifizierung erfolgt typischerweise mittels LC-MS/MS, hochauflösender Massenspektrometrie und ergänzender NMR-Analytik.
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