Buspirone EP Impurity M, auch als Buspirone Bromobutyl Analog bezeichnet, CAS 80827-62-9, ist eine bromierte prozessbedingte Verunreinigung mit der Summenformel C13H20BrNO2 und einer Molekülmasse von 302,21 g/mol. Strukturell handelt es sich um ein alkylieres Analogon des Buspiron-Gerüstes, bei dem ein Brombutyl-Substituent das entsprechende Seitenkettenmotiv ersetzt, was mit der Bildung während der Handhabung synthetischer Zwischenprodukte oder durch Nebenreaktionen der Halogenierung vereinbar ist. Aufgrund der engen physikochemischen Ähnlichkeit zum Wirkstoff sind Spurenmengen meist nur mittels LC-MS/MS, hochauflösender LC-MS und orthogonaler HPLC-Methoden mit selektiver UV- oder MS-Detektion sicher zu erfassen. Die Einordnung ist im Rahmen von Verunreinigungsprofilen und der ICH-M7-Bewertung relevant.
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