haohan药包材环氧乙烷测定6%氰丙基苯基94%二甲基聚硅氧烷的毛细管柱60m*0.25mm*1.4um

《国家药包材标准》2015年版中YBB00112004-2015《预灌封注射器组合件(带注射针)》已经规定了环氧乙烷残留量不得过1 μg/mL，测定方法为YBB00242005-2015《环氧乙烷残留量测定法》。此次4209《药包材环氧乙烷测定法》公示稿对原有测定方法【第yi法（外标法）和第二法（标准曲线法）】进行了更新，并增加了第三法（气质联用色谱法），用于药包材中环氧乙烷定性验证。

名称：毛细管柱
固定相：6%氰丙基苯基94%二甲基聚硅氧烷
规格：60m×0.25mm×1.4μm
型号：HH-624
应用：4209 药包材环氧乙烷测定法 The 2015 edition of the National Drug Packaging Material Standard, YBB00112004-2015 "Pre filled Syringe Assembly (with Injection Needle)", has stipulated that the residual amount of ethylene oxide should not exceed 1 μ g/mL, and the determination method is YBB0024205-2015 "Determination Method for Residual Amount of Ethylene Oxide". The public draft of the 4209 "Determination Method for Ethylene Oxide in Drug Packaging Materials" has updated the original determination methods, the first method (external standard method) and the second method (standard curve method), and added a third method (gas chromatography-mass spectrometry) for qualitative verification of ethylene oxide in drug packaging materials.
Name: Capillary Column
Fixed phase: 6% cyanopropyl phenyl 94% dimethyl polysiloxane
Specification: 60m × 0.25mm × 1.4 μ m
Model: HH-624
Application: 4209 Determination of Ethylene Oxide in Pharmaceutical Packaging Materials