Amikacin EP Impurity H, CAS 48237-20-3 は、アミカシンのヘプトース/アミノシクリトール骨格に関連する、構造が規定されたアミノグリコシド系プロセス不純物であり、分子式 C22H44N6O12、分子量 584.62 g/mol を有する。これは、半合成アミノグリコシド製造過程における不完全なグリコシル化、トランスグリコシル化、または後期変換に由来しうる、近縁のクロマトグラフィー変異体である。高い極性、ポリカチオン性、および高度に酸素化された構造のため、分離には通常、イオンペアまたは HILIC-LC と高分解能 MS、あるいは LC-MS/MS が必要となる。規制上の不純物評価では、効力、微生物学的応答、規格設定への影響が検討される。
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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