2023年1月，國(guó)家藥典委員會(huì)發(fā)布了4209《藥包材環(huán)氧乙烷測(cè)定法》公示稿，用于檢測(cè)經(jīng)過(guò)環(huán)氧乙烷滅菌的預(yù)灌封注射器組合件、滴眼劑瓶等藥品包裝材料中環(huán)氧乙烷殘留量。

　　4209《藥包材環(huán)氧乙烷測(cè)定法》公示稿對(duì)原有測(cè)定方法【第一法（外標(biāo)法）和第二法（標(biāo)準(zhǔn)曲線法）】進(jìn)行了更新，并增加了第三法（氣質(zhì)聯(lián)用色譜法），用于藥包材中環(huán)氧乙烷定性驗(yàn)證。

　　浩瀚色譜依據(jù)藥典標(biāo)準(zhǔn)，研制生產(chǎn)HH-624毛細(xì)管柱測(cè)定4209《藥包材環(huán)氧乙烷測(cè)定法》，乙醛不干擾，柱效高，結(jié)果滿意。

　　名稱:毛細(xì)管柱

　　固定相:6%氰丙基苯基94%二甲基聚硅氧烷

　　規(guī)格:60m×0.25mm×1.4μm

　　型號(hào):HH-624

　　應(yīng)用:4209 藥包材環(huán)氧乙烷測(cè)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