2023年1月，国家药典委员会发布了4209《药包材环氧乙烷测定法》公示稿，用于检测经过环氧乙烷灭菌的预灌封注射器组合件、滴眼剂瓶等药品包装材料中环氧乙烷残留量。

　　4209《药包材环氧乙烷测定法》公示稿对原有测定方法【第一法（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。

　　浩瀚色谱依据药典标准，研制生产HH-624毛细管柱测定4209《药包材环氧乙烷测定法》，乙醛不干扰，柱效高，结果满意。

　　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

　　In January 2023, the National Pharmacopoeia Commission released a public draft of 4209 "Determination Method for Ethylene Oxide in Pharmaceutical Packaging Materials", which is used to detect the residual amount of ethylene oxide in pre filled syringe assemblies, eye drops bottles and other drug packaging materials that have been sterilized with ethylene oxide.

　　The public draft of 4209 "Determination Method for Ethylene Oxide in Drug Packaging Materials" has updated the original determination methods of 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.

　　According to the pharmacopoeia standards, Haohan Chromatography has developed and produced HH-624 capillary column for the determination of 4209 "Determination of epoxyethane in pharmaceutical packaging materials". Acetaldehyde does not interfere, the column efficiency is high, and the results are satisfactory.

　　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