Amikacin EP Impurity I(CAS 40371-51-5)는 아미카신의 불순물 프로파일에 포함되는 저분자 아민화 분해 관련 불순물로, 독립적인 약리활성 성분이 아니다. 분자식 C4H9NO3, 분자량 119.12 g/mol의 고극성 다기능 산소 함유 아민으로, 크로마토그래피 분리에 이온쌍 또는 HILIC 조건이 자주 요구된다. 미량 정량은 일반적으로 LC-MS/MS로 수행되며, 구조 확인이 필요할 경우 유도체화 기반 GC-MS가 보완적으로 사용된다. 이 물질은 공정 유래 불순물 분석, 가수분해 또는 산화 분해 평가, 그리고 약전 규격 설정과 관련된다.
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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