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

Introduction

Ethanol has antimicrobial properties and is sold as a disinfectant product at optimized concentrations. Quality control of the alcohol as a medical product is carried out through verification testing procedures as stipulated in each monograph of the Pharmacopoeias. Guided by the International Council for Harmonization on Technical Requirements for Pharmaceuticals for Human Use(ICH), the Japanese (JP), United States (USP) and European (EP) pharmacopoeias share roughly the same verification testing procedures for anhydrous ethanol and ethanol for disinfection. The Chinese Pharmacopoeia (ChP) also adopts a similar testing method. Methanol, acetaldehyde, acetal and benzene are among the volatile impurities to be monitored. An instrument is required to detect benzene down to the specified 2 vol ppm limit or lower and also obtain a good resolution between acetaldehyde and methanol. This article presents the analysis of volatile impurities in accordance with the purity test (3) of the Japanese pharmacopoeia.

July 14, 2020 GMT