Amoxicillin EP Impurity H, 즉 Amoxicillin Related Compound H는 페남(penam) 골격에서 유래한 구조 규정 분해물로서 니트로사민 계열이 아니다. CAS 205826-86-4, 분자식 C13H17NO4, 분자량 251.28 g/mol로 규정된다. 이 불순물은 아목시실린 원료의 합성, 저장 또는 취급 과정에서 발생할 수 있는 가수분해, 산화, 또는 재배열 경로와 연관된다. 유사 화합물과의 공용출 가능성 때문에 동정과 정량에는 일반적으로 LC-MS/MS, 고분해능 LC-MS, 그리고 다이오드 어레이 검출기를 갖춘 직교 HPLC가 요구되며, 구조 확인에는 NMR이 활용된다.
References
Valvo, L., et al. Development of a Simple Liquid Chromatographic Method with UV and Mass Spectrometric Detection for the Separation of Substances Related to Amoxicillin Sodium.â€Â Journal of Chromatography A, vol. 797, no. 1-2, Feb. 1998, pp. 311–16, https://doi.org/10.1016/s0021-9673(97)00952-7 Zhu, Yongxin, et al. Evaluation of Liquid Chromatography Methods for the Separation of Ampicillin and Its Related Substances.†Journal of Pharmaceutical and Biomedical Analysis, vol. 14, no. 5, Mar. 1996
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