Telmisartan EP Impurity C, also designated Telmisartan t-Butyl Ester, is a process-related ester impurity associated with the biphenyl benzimidazole angiotensin II receptor antagonist telmisartan. CAS 144702-26-1 corresponds to the neutral tert-butyl ester species with molecular formula C37H38N4O2 and molecular weight 570.72 g/mol. Its occurrence is typically linked to incomplete ester hydrolysis or side reactions during synthesis and purification rather than oxidative degradation. Because of close structural similarity to the parent API, determination generally requires orthogonal high-resolution LC-MS, LC-MS/MS, and chromatographic methods such as RP-HPLC with UV or PDA detection; GC-MS may be supportive after derivatization. It is not a nitrosamine, but remains relevant to impurity profiling and ICH-compliant specification setting.
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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