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Time:2022.09.14
Publisher:Admin
Number:1742
2022.09.14
Admin
1742
Ethylene oxide (EO) is used for disinfection of medical devices, and the residual ethylene oxide is hydrolyzed and reacts with chlorine in the product to produce 2-chloroethanol (ECH).2-chloroethanol can irritate the body surface, is acutely toxic, and can be absorbed through the skin, causing damage to a variety of organs.Currently, GB/T 16886 specifies the maximum permissible residual amount of ECH when present in medical devices sterilized with ethylene oxide.
Referring to the standard YYT1690-2020 for the determination of 2-chloroethanol residue in single-use polyvinyl chloride infusion apparatus, the detection and analysis of 2-chloroethanol was carried out with Panyu automatic headspace sampler HS-25 and Panino GC 1949.
2-The preparation of chloroethanol (ECH)
Take 500ul of 2-chloroethanol stock solution with concentration of 1000mg/L and put it into 25ml volumetric bottle to obtain 20mg/L 2-chloroethanol standard solution.
Take 4 20ml headspace vials, take 0.5ml standard solution and 4.5ml water into the headspace vial, configured as 2mg/L concentration of the sample;Take 1ml of standard solution and 4ml of water into the headspace vial and configure the sample with 4mg/L concentration;1.5ml standard solution and 3.5ml water were put into the headspace vial with 6mg/L concentration as the sample;And 2.5ml standard solution and 2.5ml water into the headspace vial with 10mg/L concentration of the sample.
Headspace conditions
Heating furnace: 90℃, valve box: 100℃, transmission line: 150℃;Pressure: 15psi, quantitative pressure: 4psi
Heating balance time: 30min, injection time: 2min
GC conditions
Column, AB-624, 60m*0.53mm*3um (HP-inowax, 30m*0.32mm*0.25um separation, poor separation effect);Inlet temperature, 250℃, shunt ratio 5:1;Column box temperature: 50℃ for 3min, 10℃/min to 100℃, keep for 2min;Column flow rate, constant flow 3ml/min;Detector FID:250℃, hydrogen 30ml/min;Air 300ml/min, nitrogen(make up gas) 25ml/min
Partial Results
Calibration curve:
Spectrogram at a concentration of 10ug/ml
The spectrum at a concentration of 2ug/ml
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