Effect of pH value on the quality of flumazenil injection
Objective To determine the effect of pH values on the quality of flumazenil injection and provide a basis for the control of pH during the production process.Methods Flumazenil injections with pH values of 3.0,3.4,3.8,4.2,4.6 and 5.0 were prepared and placed in the long-term and accelerated stability test chambers together with the reference preparations.The samples were taken out after 1,3,6 months and the key indicators were tested to evaluate the stability differences between flumazenil injections with different pH values and reference preparations.Results The characteristics,clarity and color of solution,visible particles and insoluble particles of all samples did not change during the stability test,and the content did not change obviously.Impurity A obviously tended to increase while no other impurities were detected in the related substances.When the pH value ranged 3.8～4.6,the growth of impurity A in the self-made flumazenil injections relatively slowed down,which was similar to that in the reference preparation.Conclusion Flumazenil injection is more stable when the pH value ranges 3.8～4.6.
万方数据
维普
