Amikacin EP Impurity H, CAS 48237-20-3은 아미카신의 헵토스/아미노시클리톨 골격과 연관된 구조 규정형 아미노글리코사이드 계열 공정 불순물로, 분자식 C22H44N6O12 및 분자량 584.62 g/mol을 가진다. 이 분석물은 반합성 아미노글리코사이드 제조 중 불완전한 글리코실화, 트랜스글리코실화 또는 후기 변환에서 생성될 수 있는, 밀접하게 관련된 크로마토그래피 변이체이다. 강한 극성, 폴리양이온성, 고산소화 구조 때문에 분리는 일반적으로 이온쌍 또는 HILIC-LC와 고분해능 MS 또는 LC-MS/MS의 결합을 필요로 한다. 규제적 불순물 프로파일링에서는 이러한 종이 효능, 미생물학적 반응, 규격 설정에 미치는 영향 때문에 평가된다.
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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