Current status and considerations on the control of ethylene glycol,diethylene glycol,and triethylene glycol impurities in pharmaceutical excipients
WANG Jue
WANG Xiao-feng
ZHANG Xue-yan
ZHAO Xia
NING Bao-ming
LING Xiao
TU Jia-sheng
YANG Rui
ZHANG Jun
SUN Hui-min
Abstract：This article provides an in-depth exploration of the current quality control status and regulatory developments concerning ethylene glycol,diethylene glycol,and triethylene glycol impurities in pharmaceutical excipients.Since the 1940s,global public safety incidents caused by the misuse or contamination of ethylene glycol or diethylene glycol have occurred frequently,drawing significant attention from regulatory authorities worldwide.Regulatory agencies have introduced corresponding measures to prevent the recurrence of such incidents.The article details the sources,uses,safety profiles of ethylene glycol,diethylene glycol,and triethylene glycol,as well as their respective pharmacopoeial standards and the current regulatory landscape.Testing for the presence of these three impurities in representative excipient products has revealed potential risks posed by ethylene glycol,diethylene glycol,and triethylene glycol in pharmaceutical excipients.Based on these findings,the article proposes recom-mendations for strengthening detection standards,enhancing regulatory oversight,and improving safety assessments to ensure the safety of pharmaceutical excipients and prevent similar pharmaceutical disasters.The results indicate that establishing rigorous detection methods and standards for these three impurities is crucial for ensuring the overall quality and safety of pharmaceuticals,especially in the quality control of excipients,which should be given equal importance as that of active pharmaceutical ingredients.
Keywords：pharmaceutical excipientsethylene glycoldiethylene glycoltriethylene glycolimpurityquality control
Publication Date：2026-04-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：12( 710-721 )