ETO residue testing method in finished product

Dear Forum,

we are searching for testing method for determination of Ethylene oxide in finished product. can any one help me in this regard?


For Medical Devices:
This test is used to determine the concentration of Ethylene Oxide as well as it’s two breakdown products: Ethylene Chlorohydrin and Ethylene Glycol. In recent years testing is done to the ANSI/AAMI/ISO 10993-7 standard. The upside to this method is that it strives to simulate the actual use of the product. Concentrations vary based on whether the device comes in contact with skin, blood/mucosa or areas that may come in contact with the fetus.

For Pharmaceuticals:

[b]Determination of ethylene oxide, ethylene chlorohydrin, and ethylene glycol residues in ophthalmic solutions at proposed concentration limits

Journal of Pharmaceutical Sciences (December 1979), 68 (12), pg. 1547-1549[/b]