Summary
A GC headspace test procedure has been developed for the determination of ethylene oxide (EO) in raw materials produced totally or partly from ethylene oxide. This procedure described is a limit test for EO within the concentration range 0.5–2.5 μg/g. The determination is based on the standard addition method and is suitable for testing whether an upper limit of 1 μg/g of EO is exceeded in pharmaceutical raw materials.
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Tegewa Determination of monomeric ethylene oxide in pharmaceutical raw materials. Z. Anal. Chem. 333, 26–28 (1989). https://doi.org/10.1007/BF00572612
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DOI: https://doi.org/10.1007/BF00572612