Amikacin EP Impurity I (CAS 40371-51-5) é descrita como uma impureza aminada de baixo peso molecular, associada ao perfil de degradação da amicacina, e não como um constituinte farmacologicamente ativo independente. Com fórmula molecular C4H9NO3 e massa molecular de 119.12 g/mol, corresponde a uma amina oxigenada, altamente polar e multifuncional, cuja resolução cromatográfica frequentemente exige cromatografia de troca iônica ou HILIC. A determinação em nível traço é tipicamente realizada por LC-MS/MS, podendo ser complementada por GC-MS com derivatização quando é necessária confirmação estrutural. Sua presença é relevante para o mapeamento de impurezas de प्रक्रिया, avaliação de degradação hidrolítica ou oxidativa e definição de limites farmacopeicos.
Referências
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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