haohan毛细管测定*中环氧乙烷的残留量SE-54

 

近年来，环氧乙烷广泛用于*的消毒灭菌，但残留量过高对人体有很大的危害，如引起溶血、组织坏死、过敏反应和致癌等川。因此，*中环氧乙烷残留量的测定，已成为重要的检测项目。目前，重力式一次性输液器、一次性使用无菌注射器中环氧乙烷残留量按国家标准方法。

浩瀚色谱（山东）应用技术开发有限公司采用SE-54毛细管柱，测定*中环氧乙烷的残留量，结果:环氧乙烷在5.1920—51.920μg范围内呈线性关系(r=0.997,n=6),检测限为1μg;注射器中的环氧乙烷的平均回收率为103.3%,输液器中环氧乙烷的平均回收率为81.04%。结论:经方法学验证,该方法灵敏度、准确度均达到有机溶剂残留量测定的要求,可用于输液器、注射器中环氧乙烷残留量的测定。

 

In recent years, ethylene oxide has been widely used for the disinfection and sterilization of medical devices. However, excessive residue is harmful to human health, such as causing hemolysis, tissue necrosis, allergic reaction and carcinogenesis. Therefore, the determination of ethylene oxide residues in medical devices has become an important test item. At present, the residual amount of epoxyethane in gravity disposable infusion sets and disposable sterile syringes follows the national standard method.



Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. used SE-54 capillary column to determine the residual amount of ethylene oxide in medical devices. The results showed that ethylene oxide was 5.1920-51.920 μ Linear relationship within g range (r=0.997, n=6), detection limit is 1 μ g; The average recovery rate of ethylene oxide in the syringe was 103.3%, and the average recovery rate of ethylene oxide in the infusion set was 81.04%. Conclusion: The sensitivity and accuracy of the method meet the requirements for the determination of residual organic solvents, and can be used for the determination of residual epoxyethane in infusion sets and syringes.