Study on the quality standard and stability of edaravone injection
Abstract：Objective To establish the quality standard of edaravone injection and to investigate its stability . Methods The quantitative detection of edaravone injection was performed by HPLC , detection wavelength was 242 nm, theoretical plate number based on the chromatogram of edaravone was more than 2000 , retention time was12 ~15 min.The quality was controlled by pH , contents of heavy metals , bacterial endotoxin and sterility tests .The stability of edaravone injection was evaluated by influence factors test ,acceleration test and room temperature storage observation test .Results From 1.5 to 7.5μg/μl,the concentration and absorbance of edaravone injection had a good linear relationship ( r =0.9994),the average recovery rate was100.02%,and RSD was 0.96%.The pH of three batches injections was 2.8,2.9,2.8,respectively, moreover,the contents of heavy metals ,bacterial endotoxin and sterility tests were consistent with pharmacopoeias regulation . Conclusion The method is simple , accurate , stable and repeatable , which can effectively control the quality of edaravone injection and can assure its stability .
Keywords：edaravoneInjectionquality standardstability
Publication Date：2014-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 2098-2100 )