RESUMO
OBJECTIVE: To investigate the impurity profile of ceftizoxime sodium for injection and develop the impurity control strategy.
RESUMO
OBJECTIVE:To study the production process of ceftizoxime sodium.METHODS:Ceftizoxime acid was prepared with 7-Amino-3-norcephem-4-carboxylic acid(7-ANCA)and AE-ester ceftizoxime acid as raw material;then ceftizoxime sodium was obtained through the reaction between ceftizoxime acid and sodium carbonate.The effects of parameters including reaction time,and amount and dripping velocity of ethanol,the amount of sodium carbonate,and pH of solution on quality of product were studied.RESULTS:The reaction process could be realized successfully.The optimal parameters for the synthesis of ceftizoxime sodium were as follows:reaction time=1.5h,the velocity of dripping ethanol=400mL? h-1,reaction temperature