Quality Analysis of Carbazochrome Sodium Sulfonate Injection in National Assessment Programs / 中国药师

ABSTRACT

Objective:To evaluate the quality of carbazochrome sodium sulfonate Injection from different manufacturers, analyze the existing problems and provide the reference for the improvement of clinical medication safety. Methods:Statutory testing methods and the exploratory research methods were used to examine the samples, and the quality status of carbazochrome sodium sulfonate Injec-tion was evaluated according to the results. Results:Totally 89 batches of the samples were tested by the current standard. The quali-fied rate was 97. 8%, and the two batches of unqualified samples were carbazochrome sodium sulfonate and sodium chloride Injection with unqualified insoluble particles. Overall, the quality risk of carbazochrome sodium sulfonate for injection was low, and the safety of carbazochrome sodium sulfonate and sodium chloride Injection needed further research. Conclusion:The quality of carbazochrome so-dium sulfonate Injection basically meets the current standard, and the exploratory research suggests that the current standard is imper-fect. It is urgent to improve the related substance detection in the standard and determine the reasonable limits for the degradation im-purities and the other impurities. The clinical medication safety of carbazochrome sodium sulfonate and sodium chloride Injection needs further research.