Amikacin EP Impurity B(CAS 927821-99-6)는 반합성 4,6-이치환 deoxystreptamine계 항생제 아미카신과 관련된 구조 규정 불순물이다. 분자식 C26H50N6O15, 분자량 686.71 g/mol로서 다가 하이드록실화된 aminocyclitol 골격과 다수의 배당결합을 유지하므로, 반합성 공정, 가수분해 또는 모체 화합물의 에피머화 재배열 중 생성되는 공정 관련 또는 전환 유래 불순물로 해석된다. 아미카신과의 구조적 유사성이 높아 검출과 정량에는 고분해능 LC-MS/MS 및 이온교환 또는 HILIC의 직교 분리가 통상 요구되며, 구조 규명에는 NMR이 적용된다.
References
Ristuccia AM, Cunha BA. An overview of amikacin. Therapeutic Drug Monitoring. 1985 ;7(1):12-25. DOI: 10.1097/00007691-198503000-00003. PMID: 3887667.http://europepmc.org/article/med/3887667 Wang, Jian, et al. “Separation and Characterization of Unknown Impurities in Amikacin Sulfate by HPLC–MS N.†Chromatographia, vol. 78, no. 15-16, Springer Science+Business Media, May 2015, pp. 1031–39, https://doi.org/10.1007/s10337-015-2909-8 . Accessed 26 Oct. 2023.
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