Simple GLC determination of ethylene oxide and its reaction products in drugs and formulations

Convenient rapid GLC methods for the estimation of residual ethylene oxide, ethylene chlorohydrin, and ethylene glycol in ethylene oxide-sterilized bulk drugs and formulations prepared therefrom are described. Ethylene oxide was chromatographed using a porous polymer column; ethylene chlorohydrin and ethylene glycol were chromatographed using either polyethylene glycol 400 or a porous polymer column. All three residuals were determined from the same sample preparation for each type of drug or formulation examined. Recoveries of each of the three residuals were greater than 95% for all samples examined. Detection limits, at moderate electrometer sensitivities, were 2 microgram/g or ml for ethylene oxide and ethylene chlorohydrin and 5 microgram/g or ml for ethylene glycol. The most likely interferences are discussed.