텔미사르탄 EP 불순물 C, 즉 텔미사르탄 t-부틸 에스터는 비페닐 벤즈이미다졸계 안지오텐신 II 수용체 길항제 텔미사르탄과 관련된 공정 유래 에스터 불순물이다. CAS 144702-26-1은 중성 tert-부틸 에스터 종을 나타내며, 분자식은 C37H38N4O2, 분자량은 570.72 g/mol이다. 이 불순물의 생성은 일반적으로 합성 또는 정제 과정에서의 에스터 가수분해 불완전성이나 부반응과 연관되며, 산화 분해와는 구별된다. 모체 약물과의 구조적 유사성 때문에 확인 및 정량에는 고분해능 LC-MS, LC-MS/MS, 그리고 UV 또는 PDA 검출을 갖는 RP-HPLC가 통상 요구되며, 유도체화 후 GC-MS도 보조적으로 활용된다. 니트로사민은 아니지만, 불순물 프로파일링과 ICH 기준 설정에서 중요한 성분이다.
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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