Amoxicillin EP Impurity H, also designated Amoxicillin Related Compound H, is a structurally defined penam-derived degradant associated with beta-lactam instability rather than a nitrosamine class hazard. CAS 205826-86-4 identifies the entity with molecular formula C13H17NO4 and molecular weight 251.28 g/mol. The impurity is relevant to oxidative, hydrolytic, or rearrangement pathways arising during synthesis or storage of amoxicillin materials. Because the chromophore and ionic profile may overlap with related substances, its characterization typically requires LC-MS/MS, high-resolution LC-MS, and orthogonal HPLC with diode-array detection; NMR may be used for structural confirmation under compendial impurity mapping.
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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