50725-24-1Amikacin EP Impurity A

● Under Development

Catalogue No.:	VL6230001
CAS No.:	50725-24-1
Mol. Formula:	C22H43N5O13
Mol. Weight:	585.60 g/mol

How can we help?

Add to RFQ list

Additional information on CAS 50725-24-1

Parent drug

Amikacin

IUPAC Name

4-O-(3-amino-3-deoxy-α-D-glucopyranosyl)-6-O-(6- amino-6-deoxy-α-D-glucopyranosyl)-1-N-[(2S)-4-amino- 2-hydroxybutanoyl]-2-deoxy-L-streptamine

Synonyms

N/A

Description

Amikacin EP Impurity A (CAS 50725-24-1) is a defined aminoglycoside-related process impurity associated with the semisynthetic neomycin derivative amikacin. With molecular formula C22H43N5O13 and molecular weight 585.60 g/mol, it is structurally consistent with a closely related glycosidic species arising from incomplete acylation, side-chain transfer, or related synthetic divergence during manufacture. Its highly polar, polycationic character limits reversed-phase retention and usually necessitates ion-pair or hydrophilic interaction LC coupled to MS or tandem MS for sensitive characterization. Because trace aminoglycoside impurities may affect toxicological assessment, this compound is typically treated within impurity profiling frameworks under pharmacopeial and ICH-oriented control strategies.

References

Ristuccia AM, Cunha BA. An overview of amikacin. Therapeutic Drug Monitoring. 1985 ;7(1):12-25. DOI: 10.1097/00007691-198503000-00003. PMID: 3887667.http://europepmc.org/article/med/3887667 Wang, Jian, et al. â€œSeparation and Characterization of Unknown Impurities in Amikacin Sulfate by HPLCâ€“MS N.â€ ResearchGate, Springer Nature, 30 Aug. 2015, www.researchgate.net/publication/277921697_Separation_and_Characterization_of_Unknown_Impurities_in_Amikacin_Sulfate_by_HPLC-MS_n. Accessed 27 Oct. 2023.