顶空气相色谱法测定醋酸烯诺孕酮埋植剂中环氧乙烷的残留量

Determination of the Residual Ethylene Oxide in Nestorone Implant by GC

用顶空气相色谱法测定醋酸烯诺孕酮埋植剂中环氧乙烷的残留量 ,结果表明 ,线性试验与精密度良好 ,平均回收率为 99.8% ,残留量为 0 .93 %。样品在灭菌后 ,室温放置 3天 ,其环氧乙烷残留量均在 0 .0 0 0 1%以下 ,符合环氧乙烷残留量应不大于 0 .0 0 1%的规定。表明采用顶空气相色谱法测定醋酸烯诺孕酮理植剂中环氧乙烷残留量 ,方法简便 ,结果准确 。

The residual ethylene oxide in nestorone implant were determined by GC.Results showed that the linear ranges and the precision were ideal.The average recovery rate was 99.8% with RSD of 0.93%.After sterilized and placed at room temperature,the residual ethylene oxide in the nestorone implant was lower 0.0001%,according with the regulation.The GC methed is simple and accurate to determine the residual ethylene oxide in nestorone implant for the determination and control of the residual ethylene oxide.