의약외품중 산화에칠렌가스의 잔류량 분석

Determination of the Residual Ethylene Oxide in Quasi-drugs

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 37oC. 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 mumin; oven temperature 50oC, injector temperature 180oC, detector temperature 200oC. The detection limit for EO was 0.10μg/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 rpm which is the limit value of FDA guideline. When the EO residues, etcylene 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.