Preparation and Compatible with Infusion Stability of Ethylenediamine Diaceturate for Injection / 中国药房

ABSTRACT

OBJECTIVE:To study the stability of ethylenediamine diaceturate(EDD)for injection and compatible stability of 3 kinds of clinically common infusions.METHODS:The experiement of influencing factors(including light,high temperature,10 days)was carried out meanwhile the accelerated test(6 months)was performed for the preparation under the condition of being packaged;the stability of EDD in 5% glucose injection,10% glucose injection or in 0.9% sodium chloride injection within 8.0 h were observed.The major outcome measures were appearance,visible foreign substances,pH value,contents of principal agent(area of the chief peak),the relative substances and 5-hydroxymethyl furfural,etc.RESULTS:No marked change was noted for all the outcome measures except a slight increase of the content of the related substances in the light exposure test.CONCLUSION:EDD for injection stored away from light at room temperature shows good stability,and it is stable within 8.0 h after mixing with 3 kinds of common infusions.