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