Quality Analysis and Risk Assessment of Commercially Available Cefixime Granules
Objective To analyze the quality of cefixime granules in the market,and to provide reference for improving the uniformity of product quality and standard testing methods.Methods A total of 28 batches of cefixime granules from 7 manufacturers were tested by legal test method,and the test results were analyzed statistically.The dissolution curve was determined to find out the difference of dissolution behavior between the imitation sample and the original drug.The product polymers and related substances were measured,and the changes of polymers and specific impurities under different temperature and humidity storage conditions were investigated.Results All 28 batches of samples passed the inspection according to the statutory standards.However,there were inconsistencies between the inspection standards,storage conditions,whether sugar was present,and the product labeling.Significant differences were observed in three areas:moisture content,in vitro dissolution,and polymer.Only 1 of the 7 production enterprises controlled the polymer,3 of the 6 production enterprises did not control the polymer,the product polymer test results were high,close to or equal to the standard limit,the dissolution curve of the A production enterprise was significantly different from that of other enterprises,and the average water content of the D production enterprise was much higher than that of other enterprises.High humidity conditions lead to increased levels of polymers and specific impurities.Conclusion The overall quality of cefixime granules is qualified,but it is still necessary to further improve the unified standard and strengthen the quality control.
万方数据
维普
