Amikacin EP Impurity I (CAS 40371-51-5) ist als niedermolekulare, aminierte und abbauassoziierte Verunreinigung im Impuritätsprofil von Amikacin zu bewerten, nicht als eigenständiger pharmakologisch aktiver Bestandteil. Mit der Summenformel C4H9NO3 und einer Molekülmasse von 119,12 g/mol handelt es sich um eine hochpolare, mehrfach funktionalisierte sauerstoffhaltige Aminverbindung, die für die chromatographische Trennung häufig Ionenaustausch- oder HILIC-Methoden erfordert. Die Bestimmung im Spurenbereich erfolgt typischerweise mittels LC-MS/MS, bei Bedarf ergänzt durch derivatisierungsunterstützte GC-MS zur Strukturabsicherung. Der Stoff ist für Prozessverunreinigungsprofile, hydrolytische oder oxidative Abbaupfade und pharmakopöische Grenzwertableitungen relevant.
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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