Telmisartan EP Impurity H, auch bezeichnet als Telmisartan Bromo t-Butyl Ester, CAS 114772-40-6, ist ein bromiertes Ester-Zwischenprodukt der Telmisartan-Prozesschemie und kein klassisches Abbauprodukt. Die Zusammensetzung C18H19BrO2 mit einer Molekülmasse von 347.25 kennzeichnet ein lipophiles Arylbromid-Gerüst, das aus unvollständiger Umsetzung oder Nebenreaktionen bei der Synthese des Biphenyltetrazol-Antihypertensivums entstehen kann. Da bromierte Verunreinigungen in Spuren persistieren und das Verunreinigungsprofil beeinflussen, erfolgt die Charakterisierung typischerweise mittels LC-MS/MS, hochauflösender LC-MS und ergänzender HPLC-UV-Methoden; GC-MS kann die Beurteilung flüchtiger Restverunreinigungen unterstützen. Es handelt sich nicht um ein Nitrosamin, bleibt jedoch regulatorisch relevant.
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