Amikacin EP Impurity E
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50866-72-3Amikacin EP Impurity E

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Catalogue No.:VL6230005
CAS No.:50866-72-3
Mol. Formula:C22H43N5O13
Mol. Weight:585.6 g/mol

Additional information on CAS 50866-72-3

Parent drug

Amikacin

IUPAC Name

4-O-(3-amino-3-deoxy-α-D-glucopyranosyl)-6-O-[6-[[(2S)-4-amino-2-hydroxybutanoyl]amino]-6-deoxy-α-Dglucopyranosyl]-2-deoxy-L-streptamine

Synonyms

N/A

Description

Amikacin EP Impurity E (CAS 50866-72-3) is a defined aminoglycoside-related process and degradant impurity associated with the kanamycin-derived aminocyclitol scaffold of amikacin. With molecular formula C22H43N5O13 and molecular weight 585.6 g/mol, it retains the polyhydroxylated, polycationic profile characteristic of this class, indicating a closely related structural variant rather than a low-mass reagent contaminant. Its occurrence is typically linked to incomplete functional group transformation or downstream degradation during manufacture and storage. Determination generally requires orthogonal LC-MS/MS, high-resolution LC-MS, and ion-pair or hydrophilic interaction LC methods, with derivatization or MS optimization often necessary for trace-level quantification in pharmacopoeial impurity profiling.

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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