Objective This research evaluated the quality status of ceftazidime for injection.Methods Using statutory testing procedures in conjunction with exploratory research,177 batches of ceftazidime for injection,manufactured by 36 companies,and one batch of the original medication were compared.The quality differences of products from different manufacturers were analyzed by investigating key quality attributes such as impurity profiles,compatible stability and packaging material compatibility.Results All 177 batches of ceftazidime for injection complied with the requirements.However,there were still some problems in the specifications,such as inconsistent determination methods and limits for some items and so on.Also,the description of drug instructions was inconsistent.In the exploratory study,the impurity analysis method was optimized,and the possible structure of impurities in the product was inferred by LC/MS and their source was analyzed.The results of compatible stability tests showed that the drug instructions of some manufacturers were unreasonable and there were hidden risks.Conclusion The overall quality of ceftazidime for injection was acceptable,but the current specification needed to be unified and improved.
Ceftazidime for injectionNational drug samplingQuality analysis
万方数据
维普
