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Shanghai Jinghe Analytical Instrument Co., Ltd

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Analyze Elf G60-HS pharmaceutical ethylene oxide residue specific gas chromatograph

NegotiableUpdate on 01/21
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Overview

Brief description: Ethylene oxide detection gas chromatograph, EO residue detection gas chromatograph, pharmaceutical ethylene oxide residue dedicated gas chromatograph AnalyElf HS-G60 is suitable for the detection of ethylene oxide residue in all disposable medical supplies disinfected and sterilized with ethylene oxide sterilization devices. It also applies to all applications that require the use of headspace gas chromatography to detect residues or monomers

Product Details

Pharmaceutical ethylene oxide residue specific gas chromatographAnalyElfG60-HS

summary:

Applicable to the detection of residual ethylene oxide in disposable medical supplies disinfected and sterilized using ethylene oxide sterilization devices;

We rigorously inspect and test every residual ethylene oxide gas chromatograph that leaves the factory to ensure the accuracy and stability of user analysis results.

Pharmaceutical ethylene oxide residue specific gas chromatographAnalyElfG60-HS

Execution standard:

GB/T 14233.1-2008 "Methods for inspection of infusion, transfusion, and injection equipment - Part 1: Chemical analysis methods.

Biological Evaluation Part 7 of GB/T 16886.7-2015- Residual Ethylene Oxide Sterilization

Test principle:

At a certain temperature, extract ethylene oxide (EO) from the sample using an extractant water, and determine the content of EO using headspace gas chromatography.

Instruments and reagents:

Instrument: AHS-900A fully automatic headspace sampler, gas chromatograph AnalyElf G60-FID, 3095 network version reverse control workstation, 20ml headspace vial.

Standard substance: Ethylene oxide, concentration 10mg/ml.

Spectrum of epoxyethane standard sample:

环氧乙烷6次进样谱图叠加.png

Figure: Overlapping spectra of six points at 1ppm, 2ppm, 4ppm, 6ppm, 8ppm, and 10ppm


Ethylene oxide calibration curve:

环氧乙烷6点进样校正曲线.png


图片13.png


Injection method: Headspace sampler+Split injection

Detector:FID

Peak order:1Ethylene oxide;

Applicability: Detection of residual ethylene oxide in drugs and masks


Chromatographic conditions:

chromatographic column:KB-Wax,30m×0.32mm×0.50umMax Temperature:260/270℃, carrier gasN2,Purity ≥99.999%Carrier gas flow rate:28mL/min(N2)Diversion:24.5ml/minTail blowing:25ml/minDiaphragm blowing:2.0ml/minColumn flow rate:1.5ml/minHydrogen flow rate:30ml/minAir flow velocity:300ml/min

Carrier gas pressure:0.08MPAHeadspace pressure:8kpa

Column box temperature:70℃; Detector temperature:250℃; Injector temperature:230℃。


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