Impurity Profile Study of Cefradine Dihydrate / 中国药学杂志

ABSTRACT

OBJECTIVE: To study the impurity profile of cefradine dihydrate. METHODS: The impurity peaks of cefradine dihydrate were identified using column-switching technique and LC-MS, and the origination of the impurities were investigated by the forced degradation study. RESULTS: The impurity profile of cefradine dihydrate included fourteen impurities, nine of them were structure known impurities controlled by EP, two of them were newly identified impurities and three of them were structure unknown impurities. CONCLUSION: The origination and influence factors of the impurities are investigated though the impurity profile study of cefradine dihydrate, and it can provide reference for the quality control of cefradine dihydrate.