國家藥典委擬制定藥包材環(huán)氧乙烷測(cè)定法標(biāo)準(zhǔn)，為確保標(biāo)準(zhǔn)的科學(xué)性、合理性和適用性.
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將“對(duì)照品溶液應(yīng)連續(xù)進(jìn)樣不少于3次，所得待測(cè)物峰面積的RSD應(yīng)不大于10%”修改為“對(duì)照品溶液連續(xù)進(jìn)樣5次，所得待測(cè)物峰面積的RSD應(yīng)不大于10%”。
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浩瀚色譜(山東）應(yīng)用技術(shù)開發(fā)有限公司，根據(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)氧乙烷殘留》，乙醛不干擾，柱效高，結(jié)果滿意。
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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
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The National Pharmacopoeia Commission plans to develop a standard for the determination of epoxyethane in pharmaceutical packaging materials to ensure the scientific, rational, and applicable nature of the standard
The reference solution should be injected continuously no less than 3 times, and the RSD of the peak area of the analyte should not exceed 10% "should be modified to" The reference solution should be injected continuously 5 times, and the RSD of the peak area of the analyte should not exceed 10% ".
Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has developed and produced HH-624 capillary column for the determination of 4209 "Residual epoxyethane in pharmaceutical packaging materials" according to pharmacopoeia standards. 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
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