Amikacin EP Impurity A(CAS 50725-24-1)는 반합성 아미노글리코사이드계 항균제 아미카신과 연관된 정의된 공정 불순물이다. 분자식은 C22H43N5O13, 분자량은 585.60 g/mol이며, 불완전한 아실화, 측쇄 전달 또는 제조 중의 합성 경로 분기에서 유래하는 근연 글리코시드 종으로 해석된다. 매우 높은 극성과 다가 양이온성 때문에 역상 크로마토그래피에서 유지가 낮아, 일반적으로 이온페어 또는 HILIC 기반 LC와 MS 또는 MS/MS 결합 검출이 필요하다. 아미노글리코사이드 계열의 미량 불순물은 독성학적 평가에 영향을 줄 수 있으므로, 약전 및 ICH 지향 불순물 프로파일링 체계에서 관리된다.
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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