Analysis of Volatile Impurities in Anhydrous Ethanol and Ethanol for Disinfection in Accordance with the Purity Test set by the Pharmacopoeias (JP, USP, EP)

As a result of a harmonization agreement, the procedures for verification testing of ethanol for disinfection or anhydrous ethanol are roughly the same in the Japanese (JP), United States (USP) and European (EP) pharmacopoeias. Methanol, acetaldehyde, acetal, benzene, etc. are checked as volatile impurities. An appropriate instrument configuration is required to detect the specified 2 vol ppm limit or lower level of trace benzene and obtain good separation for acetaldehyde and methanol.
This article presents the analysis results of volatile impurities in accordance with the Purity (3) of ethanol.