Detection of residual epoxyethane and 2-chloroethanol in medical devices

1. Analysis purpose

Use gas chromatography to detect residual levels of ethylene oxide (EO) and 2-chloroethanol (ECH) in medical devices.

2. Experimental instruments and standard samples

G51Pro gas chromatograph (SPL+wide range FID)

HS-900 semi-automatic headspace sampler (12 positions)

3097GMP version network workstation

Nitrogen: 40L steel cylinder with purity>99.999%

Air: Air Generator (XGA-2000)

Hydrogen: Hydrogen Generator (XGH-300)

Pipette gun (100ul -1000ul)

Several 50ml volumetric flasks

Ethylene oxide 10mg/ml (using water as solvent)

2-chloroethanol 10mg/ml (using water as solvent)

3. Analysis method parameters

Chromatographic parameters:

Headspace parameters:

4. Configure standard solution

a. Take 0.2ml of ethylene oxide (10mg/ml) and 0.4ml of 2-chloroethanol (10mg/ml) and add them to a 50ml volumetric flask. Add water to make up to 50ml;

The concentration is 0.2ml of ethylene oxide (40ug/ml) and 2-chloroethanol (80ug/ml) as the intermediate solution

b. Take 2.5ml of intermediate solution and 2.5ml of water, add them to a 20ml headspace bottle, seal it, and the concentration is EO: 20ug/ml ECH: 40ug/ml

c. Take 1.25l of intermediate solution and 3.75ml of water, add it to a 20ml headspace bottle and seal it. The concentration is EO: 10ug/ml ECH: 20ug/m

d. Take 0.625ml of intermediate solution and 4.375ml of water, add it to a 20ml headspace bottle and seal it. The concentration is EO: 5ug/ml ECH: 100ug/m

e. Take 0.25ml of intermediate solution and 4.75ml of water, add it to a 20ml headspace bottle and seal it. The concentration is EO: 2ug/ml ECH: 4ug/m

f. Take 0.125ml of intermediate solution and 4.875ml of water, add them to a 20ml headspace bottle and seal it. The concentration is EO: 1ug/ml ECH: 2ug/m

5. Standard sample spectrum

EO 20ug/ml ECH 40ug/ml

EO 1ug/ml ECH 2ug/ml

EO standard curve

ECH standard curve

6. Conclusion

This method uses headspace injectionChromatography, onceInjectionInFID detector simultaneously detects ethylene oxide and 2-chloroethanolThe detection limit is better than1ug/ml， Both reproducibility and linearity meet the requirements.Linear correlation coefficient of ethylene oxide analysis using this method>0.9999 or above, with a linear correlation coefficient of>0.9999 or above for the analysis of 2-chloroethanol.

IfECH residue requires a better detection limit, and it is recommended to use an ECD detector.