Amikacin EP Impurity A (CAS 50725-24-1) ist eine definierte aminoglykosidbezogene Prozessverunreinigung des halbsynthetischen Neomycin-Derivats Amikacin. Mit der Summenformel C22H43N5O13 und einer Molekülmasse von 585,60 g/mol entspricht sie strukturell einer eng verwandten glykosidischen Spezies, die durch unvollständige Acylierung, Seitenkettenübertragung oder andere synthetische Abweichungen während der Herstellung entstehen kann. Die stark polare, polykationische Natur begrenzt die Retention in der Reversed-Phase-Chromatographie und erfordert meist Ion-Pair- oder HILIC-Methoden in Kopplung mit MS oder Tandem-MS für eine empfindliche Charakterisierung. Da Spuren von Aminoglykosidverunreinigungen die toxikologische Bewertung beeinflussen können, wird diese Verbindung im Rahmen pharmakopöischer und ICH-orientierter Kontrollkonzepte erfasst.
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. “Separation and Characterization of Unknown Impurities in Amikacin Sulfate by HPLC–MS N.†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.
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