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.

中文翻译：

---

盐酸头孢替安中同质杂质的研究

在这项研究中，在盐酸头孢替安注射液中鉴定出两种异构体杂质并进行了表征。色谱柱切换HPLC-MS和NMR技术用于鉴定杂质1为头孢替安的Δ3（4）异构体。使用基于软件的计算，可以预测这些异构体杂质都不具有胚胎毒性。这项研究为头孢替安和相关头孢菌素抗生素的生产，储存和质量控制提供了参考。