Pages: 470-475
Year: 2017 Issue:  6
Journal: Chinese Journal of Antibiotics
Abstract: Objective To evaluate the suitability of statutory standard and the quality of cefoxitin sodium for injection of different domestic manufacturers.Methods According to the general requirements of national assessment programs,the standard methods combined with exploratory researches were used to evaluate the quality of cefoxitin sodium for injection.Results According to the statutory standards for the examination of the 227 batches of samples,the unqualified rate was 6.6％.The main unqualified items for the solution was the clarity,the color,and bacterial endotoxin.The results showed that the content of the individual impurities was correlated with the color of the solution,and the amount of the polymer was correlated with the color of the solution.It is necessary for the current standard to include the related substances II (polymer) inspection items,to revise the related substances limit,the color of the solution and content limit,and the water determination method.Conclusion At present the overall quality of cefoxitin sodium for injection is not satisfactory.Starting from the integrity of the test project,the rationality and validity of the test method,current standards should be further improved to ensure quality control.