一次性使用无菌注射器中残留单体检测

Detection of residual monomers in disposable sterile syringes

本研究建立了一次性使用无菌注射器中残留单体DCPD、TCD和MTF的气相检测方法。采用100%聚硅氧烷柱(30 m×0.32 mm×0.25μm),柱温155℃,载气为氮气,氢火焰离子化器(FID),进样口温度240℃,检测器温度250℃,分流比5∶1,进样量1.0μL。结果显示三种单体DCPD、TCD、MTF分离良好,在相应范围内线性关系良好,相关系数均大于0.999,平均加样回收率均在97%~102%,RSD值均小于2%。该方法专属性强、准确度高,可用于DCPD、TCD和MTF三种残留单体的检测。

We established a gas phase detection method for residual monomers DCPD,TCD and MTF in disposable sterile syringes;a 100%polysiloxane column(30 m×0.32 mm×0.25 um)was used with column temperature of 155℃.The carrier gas was nitrogen,the injection port temperature was 240℃,and the temperature of FID was 250℃,the split ratio was 5:1 and the sample volume was set at 1.0μL.The results showed that the monomers DCPD,TCD and MTF were well separated.Each monomer had a good linear relationship in the appropriate concentration range,and the correlation coefficient was greater than 0.999,the average recoveries were 97%~102%,and the RSDs were less than 2%.The method has strong specificity and high accuracy and can be used in the detection of three residual monomers of DCPD,TCD and MTF.