Telmisartan EP Impurity C, auch als Telmisartan t-Butylester bezeichnet, ist eine prozessbedingte Esterverunreinigung des biphenylischen Benzimidazol-Angiotensin-II-Rezeptorantagonisten Telmisartan. Die CAS-Nummer 144702-26-1 beschreibt die neutrale tert-Butylester-Spezies mit der Summenformel C37H38N4O2 und einer Molekülmasse von 570,72 g/mol. Ihr Auftreten ist typischerweise mit unvollständiger Esterhydrolyse oder Nebenreaktionen während Synthese und Aufreinigung verbunden, nicht mit oxidativem Abbau. Aufgrund der engen strukturellen Nähe zum Wirkstoff sind zur Bestimmung meist orthogonale Verfahren erforderlich, darunter hochauflösende LC-MS, LC-MS/MS sowie chromatographische Methoden wie RP-HPLC mit UV- oder PDA-Detektion; GC-MS kann nach Derivatisierung ergänzend eingesetzt werden. Es handelt sich nicht um ein Nitrosamin, bleibt jedoch für das Verunreinigungsprofil und die ICH-konforme Spezifikation relevant.
References
Palakurthi, Ashok K., et al. “QbD Based Development of HPLC Method for Simultaneous Quantification of Telmisartan and Hydrochlorothiazide Impurities in Tablets Dosage Form.†Practical Laboratory Medicine, vol. 21, Aug. 2020, p. e00169, https://doi.org/10.1016/j.plabm.2020.e00169.
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