Objective To identify the structures of polymer impurities in cefaclor raw materials.And the mechanisms of their production were analyzed.Methods The cefaclor forced-polymerization solution was prepared with 0.05 mol/L phosphate buffer(pH8.0)at room temperature for 4 days.The impurities in the forced-polymerization solution were separated by HPSEC method,and the structures of the impurities before the main peak were identified according to the primary and secondary precise mass information and the polymerization mechanism,combined with two-dimensional liquid desalination technology and column switching LC/MSn technology.Results Preliminary elucidation was conducted on 9 polymer impurity structures present in the cefaclor forced-polymerization solution.Concurrently,an examination was conducted on their mechanisms of production.Conclusions The cefaclor forced-polymerization solution can be used as suitable solution for the study and analysis of polymer impurities in cefaclor.The predicted polymer impurity structures in this study have important reference significance for the impurity profile study and quality control of cefaclor raw materials and their preparations.
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