Frontiers in Chemistry (Jan 2021)

Study on Isomeric Impurities in Cefotiam Hydrochloride

  • Ye Tian,
  • Xiao-Meng Chong,
  • Ying Liu,
  • Ying Han,
  • Chang-Qin Hu,
  • Shang-chen Yao,
  • Ming-Zhe Xu

DOI
https://doi.org/10.3389/fchem.2020.619307
Journal volume & issue
Vol. 8

Abstract

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In this study, two isomeric impurities were identified in cefotiam hydrochloride injection preparation and were characterized. Column-switching HPLC-MS and NMR techniques were used to identify the impurity 1 as the Δ3(4) isomers of cefotiam. Using software-based calculations, it was predicted that neither of the isomeric impurities was embryotoxic. This study provides a reference for the production, storage, and quality control of cefotiam and related cephalosporin antibiotics.

Keywords