Amikacin EP Impurity C, CAS 50725-25-2, is a defined aminoglycoside-related process impurity associated with the amikacin framework, reflecting structural deviation within the aminocyclitol glycoside scaffold. With molecular formula C22H43N5O13 and molecular weight 585.60 g/mol, it retains the densely hydroxylated, polycationic character typical of this class. Such impurities may arise during semisynthetic glycosylation, selective deprotection, or hydrolytic transformation of protected intermediates. Due to close chromatographic behavior and limited UV chromophore, characterization commonly relies on LC-MS/MS, high-resolution LC-MS, and hydrophilic interaction chromatography, with confirmatory NMR where required. Its presence is evaluated under impurity-control expectations for aminoglycosides.
References
Ramirez, Maria, and Marcelo Tolmasky. “Amikacin: Uses, Resistance, and Prospects for Inhibition.†Molecules, vol. 22, no. 12, Dec. 2017, p. 2267, https://doi.org/10.3390/molecules22122267 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.?
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