According to the requirements of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the structures of impurities in pharmaceutical products present at over 0.1% need to be confirmed. Therefore, the aim of this study is to separate and identify the impurities in cephapirin sodium drug substances, so as to guide the industry to improve the production process and storage conditions and reduce the impurity content in the product.

中文翻译：

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用双液相色谱-离子阱/飞行时间质谱联用技术研究头孢氨苄钠中△3-异构体的杂质分布和特征性裂解

根据国际人用药品注册技术要求统一会议（ICH）的要求，需要确定含量超过0.1％的药品中杂质的结构。因此，本研究的目的是分离鉴定头孢氨苄钠原料药中的杂质，以指导行业改善生产工艺和贮存条件，降低产品中的杂质含量。