Although the identification of degradation products of cefpirome sulfate has been reported, there has been no report concerning the impurities in bulk samples of this compound. To meet the requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the structures of impurities whose content are over 0.1% need to be confirmed. Thus, characterization of the impurities in cefpirome sulfate bulk sample is critical for controlling the production of this drug.

中文翻译：

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液相色谱-串联质谱法分离和表征硫酸头孢匹罗中的杂质和异构体以及肟型头孢菌素的裂解途径总结

虽然已经报告了硫酸头孢匹罗降解产物的鉴定，但没有关于该化合物散装样品中杂质的报告。为了满足国际人用药品技术要求协调委员会（ICH）的要求，含量超过 0.1% 的杂质的结构需要确认。因此，硫酸头孢匹罗散装样品中杂质的表征对于控制该药物的生产至关重要。