Acalabrutinib N-Oxid ist eine definierte oxidativ bedingte, prozessbezogene Verunreinigung des BTK-Inhibitors Acalabrutinib, die vorwiegend durch N-Oxidation der tertiären Aminfunktion während Synthese, Lagerung oder durch Kontakt mit Peroxiden und anderen reaktiven Sauerstoffspezies entsteht. Mit der Summenformel C26H23N7O3 und einem Molekulargewicht von 481,52 g/mol zeigt die Spezies gegenüber dem Wirkstoff eine veränderte Polarität und chromatographische Retention, weshalb zur eindeutigen Identifizierung und Quantifizierung typischerweise LC-MS/MS, hochauflösende Massenspektrometrie und orthogonale HPLC-Verfahren erforderlich sind. Obwohl kein Nitrosamin, wird sie im Rahmen von ICH Q3A/Q3B und verwandten Abbauprodukt-Konzepten bewertet.
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