Pages: 486-490
Year: 2017 Issue:  6
Journal: Chinese Journal of Antibiotics
Abstract: Objective To evaluate the suitability of statutory standard and the quality condition of meropenem for injection of different domestic manufacturers.Methods Official method was used to test the samples combined with the exploratory research.Then the results were treated by using the statistical method to evaluate the quality of meropenem for injection.Results According to the statutory standards for the examination,the qualified rate of the 115 batches of samples was 99.1％.The unqualified items were the clarity and color of the solution.The method of related substances test was optimized.This paper also researched the structures and sources of major impurities.The clarity of the solution was related to the pH value and the specifications mostly.The content of the impurities,the color of the solution and the polymer were all correlated with the sodium carbonate content.The result of exploratory research also showed that the stability of the mixtures of meropenem for injection was not positive.Conclusion With the overall,the quality of meropenem for injection general at present is positive.The statutory standard needs to be improved such as related substances test and determination of sodium carbonate.In order to improve the quality of products,the manufacturers should optimize their formulations.