Amikacin EP Impurity E(CAS 50866-72-3)는 아미카신의 카나마이신 유래 아미노시클리톨 골격과 연관된 아미노글리코사이드 계열의 공정 및 분해 불순물이다. 분자식 C22H43N5O13, 분자량 585.6 g/mol로서, 이 계열의 특징인 다가 하이드록실화 및 다가 양이온성 특성을 유지하므로 저분자 시약 불순물이 아니라 구조적으로 밀접한 변이체로 해석된다. 그 생성은 일반적으로 제조 중 불완전한 기능기 전환 또는 저장 및 가공 중 후속 분해와 관련된다. 검출과 정량에는 통상 LC-MS/MS, 고분해능 LC-MS, 그리고 이온페어 또는 HILIC 기반 LC가 필요하며, 미량 수준의 불순물 프로파일링에서는 유도체화 또는 MS 조건 최적화가 요구되는 경우가 많다.
References
Wang, Jian, et al. “Separation and Characterization of Unknown Impurities in Amikacin Sulfate by HPLC–MS N.†Chromatographia, vol. 78, no. 15-16, May 2015, pp. 1031–39, https://doi.org/10.1007/s10337-015-2909-8.?Adams, E., et al. “Analysis of Amikacin by Liquid Chromatography with Pulsed Electrochemical Detection.†Journal of Chromatography A, vol. 819, no. 1-2, Sept. 1998, pp. 93–97, https://doi.org/10.1016/s0021-9673(98)00394-x.
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