Amikacin EP Impurity I (CAS 40371-51-5) is identified as a low-molecular-weight aminated degradation-related impurity associated with the amikacin impurity profile rather than a discrete pharmacologically active constituent. With molecular formula C4H9NO3 and molecular weight 119.12 g/mol, it is consistent with a highly polar, multifunctional oxygenated amine that typically requires ion-pair or hydrophilic interaction chromatography for chromatographic resolution. Trace-level determination generally relies on LC-MS/MS, often complemented by derivatization-assisted GC-MS when structural confirmation is required. Its occurrence is relevant to process-related impurity mapping, hydrolytic or oxidative breakdown assessment, and pharmacopeial specification setting.
References
YAMADA, Yasuhiro, and Hirosuke OKADA. “Synthesis of DL-4-Amino-2-Hydroxybutyric Acid.†Agricultural and Biological Chemistry, vol. 40, no. 7, 1976, pp. 1437–38, https://doi.org/10.1271/bbb1961.40.1437. ? ?
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