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REVIEW
Methods for the detection of ethylene glycol and diethylene glycol in medicinal preparations: relevance, classical and promising screening approaches
1 Yaroslavl State Medical University, Yaroslavl, Russia
2 Information and methodological center for examination, accounting and analysis of circulation of medical products, Moscow, Russia
Correspondence should be addressed: Elena G. Lileeva
Revolutsionnaya str., 5, Yaroslavl, 150000, Russia; ur.xednay@6002aveelile
Author contribution: Lileeva EG — scientific supervision, methodological support, final editing and approval of the text; Fomina IA — literature selection and analysis, and text writing; Galeeva EV — literature selection and analysis, and text editing; Chekanova YuV — text editing; Bocharova IV — text editing.
This review summarizes and analyses methods for controlling ethylene glycol (EG) and diethylene glycol (DEG) impurities in pharmaceutical products. Contamination of medicinal products with these substances threatens the safety of patients, which is confirmed by numerous mass poisoning incidents throughout history and in modern times. The main reason is using toxic glycols instead of safe fillers such as propylene glycol and glycerol. The article presents systematic review of modern EG and DEG determining methods that range from standard pharmacopoeia methods to perspective screening tools. Particular attention is given to the relevance of development and implementation of prompt, precise and affordable screening solutions to be used at all stages of the pharmaceutical supply chain. The World Health Organization (WHO) Initiatives, including the target product profile (TPP), which aims to enforce these solutions, have been reviewed. It is emphasized that shifting from traditional centralized laboratory testing to decentralized methods is essential to prevent falsification and ensure safety of patients.
Keywords: ethylene glycol, diethylene glycol, pharmacopoeia analysis, chromatography, drug adulteration, pharmaceutical safety, screening methods, World Health Organization (WHO)