Amikacin EP Impurity E (Sulfate Salt)

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Catalogue No.:	VE0011342
CAS No.:	N/A
Mol. Formula:	C22H45N5O17S
Mol. Weight:	683.68 g/mol

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Additional information on Amikacin EP Impurity E (Sulfate Salt)

Parent drug

Amikacin

IUPAC Name

(S)-4-amino-N-(((2R,3S,4S,5R,6S)-6-(((1R,2S,3S,4R,5R)-4,5-diamino-3-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)methyl)-2-hydroxybutanamide sulfate

Synonyms

Amikacin Sulfate Impurity E (As per 35.1 EP Monograph); 6-O-(6-amino-6-deoxy-a-D-glucopyranosyl)-4-O-[5-[[(2S)-4-amino-2-hydroxybutanoyl]amino]-3-deoxy-a-Dglucopyranosyl]-2-deoxy-D-streptamine

Description

Amikacin EP Impurity E (Sulfate Salt) is a defined related substance of the aminoglycoside amikacin, corresponding to a sulfated derivative within the polyhydroxylated aminocyclitol glycoside framework. With molecular formula C22H45N5O17S and molecular weight 683.68 g/mol, it is structurally consistent with a charged sulfate counterion and extensive polarity, properties that strongly influence chromatographic retention and ionization. Such impurities may arise during semisynthetic modification, salt formation, or controlled degradation of the parent antibiotic. Characterization and quantification typically require ion-pair or HILIC LC-MS/MS, high-resolution MS, and orthogonal IC or NMR confirmation for impurity profiling in a regulatory setting.