Amoxicillin EP-Impurity H, auch als Amoxicillin Related Compound H bezeichnet, ist ein strukturell definierter Abbau- und Nebenproduktmarker aus dem Penam-Gerüst und kein Nitrosamin. CAS 205826-86-4 kennzeichnet die Substanz mit der Summenformel C13H17NO4 und einer Molekülmasse von 251,28 g/mol. Der Stoff steht mit hydrolytischen, oxidativen oder Umlagerungswegen in Zusammenhang, die während Synthese, Lagerung oder Verarbeitung von Amoxicillin auftreten können. Aufgrund möglicher Coelutionen mit verwandten Spezies erfordert die Identifizierung in der Regel LC-MS/MS, hochauflösende LC-MS und orthogonale HPLC mit Diodenarray-Detektion; zur Strukturverifizierung wird häufig NMR herangezogen.
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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