Nilotinib EP Impurity E, 즉 Desmethylimidazole Nilotinib는 키나아제 억제제 nilotinib의 정의된 공정 유래 불순물로, 합성 중 탈알킬화 또는 경로 특이적 이종고리 형성 불완전성에서 주로 기원한다. CAS 2119583-26-3, 분자식 C27H20F3N7O, 분자량 515.49 g/mol로 정의된다. 구조적으로는 2-페닐아미노 피리미딘 핵과 치환된 이미다졸 모티프를 유지하지만, 원약과 비교해 N-알킬화 양상이 다르다. 확인 및 정량에는 LC-MS/MS, 고해상도 질량분석, 직교적 HPLC 불순물 프로파일링이 통상 요구되며, 구조 확증에는 NMR이 사용된다.
References
Kondra, S. B., et al. “A Validated Stability-Indicative UPLC Method for Nilotinib Hydrochloride for the Determination of Process-Related and Degradation Impurities.” Journal of Chromatographic Science, vol. 52, no. 8, Sept. 2013, pp. 880–85, https://doi.org/10.1093/chromsci/bmt134.?
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