Salbutamol EP Impurity J, auch als Salbutamol-Keton-Impurity, Salbutamone und Albuterol Related Compound B (freie Base) bezeichnet, ist eine nicht genotoxische Prozess- und Abbauverunreinigung des phenethanolaminischen β2-Agonisten-Gerüsts. Strukturell beruht sie auf der Oxidation der sekundären Alkoholseitenkette zum entsprechenden Keton bei Erhalt des Aminoalkohol-Motivs mit der Summenformel C13H19NO3, Molekülmasse 237,29 g/mol, CAS 156547-62-5. In der regulatorischen Verunreinigungsprofilierung erfordert die Quantifizierung im Spurenbereich typischerweise LC-MS/MS mit orthogonaler Bestätigung durch HPLC-UV oder NMR; in komplexen Matrizes kann derivatisierungsunterstützte GC-MS zur Trennung nah verwandter Catecholamin-Analoga eingesetzt werden.
References
Ullmann, N., Caggiano, S., & Cutrera, R. (2015). Salbutamol and around. Italian Journal of Pediatrics, 41(Suppl 2), A74. https://doi.org/10.1186/1824-7288-41-s2-a74
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