Telmisartan EP Impurity I, CAS 528560-93-2, ist das Methylester-Analogon der Telmisartan-Säure, formal m ethyl 2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol-1-yl]methyl]phenyl]benzoat, mit der Summenformel C34H32N4O2 und einer Molekülmasse von 528,64 g/mol. Die Verunreinigung entsteht meist durch unvollständige Esterhydrolyse oder Transesterifizierung bei der Synthese oder Lagerung von Telmisartan-Vorstufen. Als prozessbedingte Strukturverunreinigung und nicht als spezifisch genotoxische Verbindung wird sie über Verunreinigungsprofile und Grenzwertfestlegung kontrolliert. Für Nachweis und Gehaltsbestimmung sind überwiegend stabilitätsindividuelle LC-MS/MS- oder LC-UV-Verfahren erforderlich, ergänzt durch massenspektrometrische Bestätigung.
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