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:10.3389/fchem.2020.619307

Study on Isomeric Impurities in Cefotiam Hydrochloride

Front Chem. 2021 Jan 15:8:619307. doi: 10.3389/fchem.2020.619307. eCollection 2020.

Authors

Ye Tian¹, Xiao-Meng Chong¹, Ying Liu¹, Ying Han¹, Chang-Qin Hu¹, Shang-Chen Yao¹, Ming-Zhe Xu¹

Affiliation

¹ National Institutes for Food and Drug Control, Beijing, China.

Abstract

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: HPLC-MS; cefotiam hydrochloride; column switching; isomer; nuclear magnetic resonance.