A Impureza EP C de telmisartana, também designada éster t-butílico de telmisartana, é uma impureza relacionada ao processo, de natureza éster, associada ao antagonista do receptor de angiotensina II telmisartana, de núcleo benzimidazólico bifenílico. O CAS 144702-26-1 corresponde à espécie neutra éster tert-butílico, com fórmula molecular C37H38N4O2 e massa molecular de 570,72 g/mol. Sua formação está tipicamente ligada à hidrólise incompleta do éster ou a reações secundárias durante a síntese e a purificação, e não necessariamente à degradação oxidativa. Devido à elevada similaridade estrutural com o fármaco, a identificação e quantificação exigem LC-MS de alta resolução, LC-MS/MS e métodos cromatográficos como RP-HPLC com detecção UV ou PDA; GC-MS pode complementar após derivatização. Não é uma nitrosamina, mas permanece relevante para o perfil de impurezas e para o estabelecimento de especificações em conformidade com ICH.
Referências
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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