GDX-407 气相色谱测一次性输液器中环氧乙烷残留

固定相：有机担体

粒度：80-100目，60-80目

规格：2m*4mm

型号：GDX-407

应用：

GBT 14233.1-1998 医用输液、输血、注射器具检验方法 第1部分：化学分析方法

GB 19335-2003 一次性使用血路产品 通用技术条件

GB14233.1-2008-T 医用输液、输血、注射器具检验方法  第１部分：化学分析方法

医学工业灭菌等方面重要的化学灭菌剂是环氧乙烷 ,环氧乙烷属于广谱灭菌剂 ,可杀灭各种微生物 ,也可破坏肉毒毒素 ,易穿透各种纸张 ,玻璃纸、聚乙烯或聚氯乙烯薄膜。有一定的吸附性 ,在消毒后因被消毒的材料性质不同 ,其完全消散的时间也不同 ,残留的环氧乙烷在使。

滕州市浩瀚色谱仪器技术服务有限公司，建立气相色谱法测定一次性使用输液器中环氧乙烷残留量。方法采用顶空气相色谱法;氢火焰离子化检测器(F ID);GDX-407填充柱;柱温:140℃;进样口温度:220℃;检测器温度:250℃;氮气(3 ml.min-1)为载气;氢气流量:45 ml.min-1,空气流量:450 ml.min-1;分流比5∶1。结果环氧乙烷在1.0738~9.6646μg.L-1范围内线性关系良好(r=0.9997),平均回收率为98.55%,RSD=1.35%。结论本法准确、简便、灵敏度高,可以作为一次性使用输液器中环氧乙烷残留量的测定方法。

气相色谱测一次性输液器中环氧乙烷残留 图片：


Determination of ethylene oxide residues in disposable infusion sets by gas chromatography
Determination of Ethylene Oxide Residues in Disposable Infusion Sets by Gas Chromatography

Stationary phase: organic carrier

Particle size: 80-100 mesh, 60-80 mesh

Specification: 2m*4mm

Model: GDX-407

application:

GBT 14233.1-1998 Medical infusions, blood transfusions

GB 19335-2003 One-time use of blood products General technical conditions

GB14233.1-2008-T Medical infusion, blood transfusion, and injecting machines - Test methods - Part 1

An important chemical sterilizing agent in the medical industry sterilization is ethylene oxide. Ethylene oxide is a high-efficiency broad-spectrum sterilizing agent that can kill various microorganisms, also destroy botulinum toxin, and easily penetrate various papers. , cellophane, polyethylene or polyvinyl chloride film. It has a certain adsorption property. After disinfection, due to the different nature of the material to be sterilized, the time for complete dissipation is also different, and residual ethylene oxide is used.

Tengzhou Haohao Chromatography Instrument Technology Service Co., Ltd. established gas chromatography to determine the residual amount of ethylene oxide in disposable infusion sets. The method used top air phase chromatography; hydrogen flame ionization detector (F ID); GDX-407 packed column; column temperature: 140 ° C; inlet temperature: 220 ° C; detector temperature: 250 ° C; nitrogen (3 ml .min-1) is carrier gas; hydrogen flow: 45 ml.min-1, air flow: 450 ml.min-1; split ratio 5:1. Results The linear relationship of ethylene oxide in the range of 1.0738~9.6646μg.L-1 was good (r=0.9997), the average recovery was 98.55%, and the RSD was 1.35%. Conclusion This method is accurate, simple and sensitive, and can be used as a method for determining the residual amount of ethylene oxide in a single-use infusion set.

Determination of Ethylene Oxide Residues in Disposable Infusion Sets by Gas Chromatography