YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Determination of the Residual Ethylene Oxide in Quasi-drugs

의약외품중 산화에칠렌가스의 잔류량 분석

  • 이정표 (식품의약품안전청 의약품평가부 의약외품과) ;
  • 김경옥 (식품의약품안전청 의약품평가부 의약외품과) ;
  • 손경훈 (식품의약품안전청 의약품평가부 의약외품과) ;
  • 양성준 (식품의약품안전청 의약품평가부 의약외품과) ;
  • 백옥진 (식품의약품안전청 의약품평가부 의약외품과)
  • Published : 2001.10.01
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Abstract

The quasi-drugs including nonwoven fabric and gauze were sterilized using ethylene oxide (EO) gas. Residual EO in the quasi-drugs was extracted with water (20 mL of water for 1 g of sample) for 24h at 37$^{\circ}C$. Residual EO was determined using GC. The optimal analytical conditions were as follows : column, Carbowax 20M (1.D. 0.2 mm); mobile phase, helium with 30 mL/min; oven temperature 57$^{\circ}C$, injector temperature 18$0^{\circ}C$, detector temperature 20$0^{\circ}C$. The detection limit for EO was 0.10$\mu$g/mL. When the residual EO extracted from nonwoven fabric and gauze was determined, it took more than 9h to get the lower level than 25 ppm which is the limit value of FDA guideline. When the EO residues, ethylene chlorohydrine (ECH) and ethylene glycol (EG) in the 7 commercially available quasi-drugs were determined, no residual EO, ECH, EG were found from the seven commercially available quasi-drugs analyzed by this method.

Keywords

References

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