Leflunomid EP Verunreinigung B, auch als Leflunomid Related Compound B und Teriflunomid bezeichnet, ist der aktive Metabolit und die zentrale Abbauverbindung von Leflunomid und entspricht dem pharmakologisch relevanten 2-Cyano-3-hydroxy-3-methylbutanamid-Gerüst. CAS 163451-81-8; Summenformel C12H9F3N2O2; Molekulargewicht 270,21 g/mol. Dieser fluorierte Anilid-Metabolit kann bei der metabolischen Aktivierung oder beim Zerfall der Prodrug entstehen. Für den Nachweis und die Quantifizierung werden typischerweise LC-MS/MS, LC-HRMS und stabiliätsindizierende HPLC-Verfahren eingesetzt, um die Trennung von verwandten Begleitstoffen sicherzustellen. Der regulatorische Fokus liegt auf der Impuritätsqualifizierung, Metabolitencharakterisierung und dem Abgleich mit pharmakopöischen Spezifikationen.
References
Bernhard M Kirsch, Maximilian Zeyda, Karl Stuhlmeier, Johannes Grisar, Josef S Smolen, Bruno Watschinger, Thomas M Stulnig, Walter H Hörl, Gerhard J Zlabinger, Marcus D Säemann Container: Arthritis Research & Therapy Year: 2005 Volume: 7 Issue: 3 DOI: 10.1186/ar1727 URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1174963/
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