Telmisartán EP Impureza C, también designada telmisartán éster t-butilo, es una impureza relacionada con el proceso y de naturaleza éster asociada al antagonista del receptor de angiotensina II telmisartán, de estructura benzimidazólica bifenílica. El CAS 144702-26-1 corresponde a la especie neutra éster tert-butilo, con fórmula molecular C37H38N4O2 y peso molecular de 570,72 g/mol. Su presencia suele vincularse con hidrólisis incompleta del éster o reacciones secundarias durante la síntesis y la purificación, más que con degradación oxidativa. Por su similitud estructural con el principio activo, su determinación requiere habitualmente LC-MS de alta resolución, LC-MS/MS y técnicas cromatográficas como RP-HPLC con detección UV o PDA; GC-MS puede complementar tras derivatización. No es una nitrosamina, pero sí una entidad relevante para el perfil de impurezas y la especificación conforme a ICH.
Referencias
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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