Simple, At-Site Detection of Diethylene Glycol/Ethylene Glycol Contamination of Glycerin and Glycerin-Based Raw Materials by Thin-Layer Chromatography

Author:

Kenyon Allen S12,Xiaoye Shi13,Yan Wang13,Wai Har Ng14,Prestridge Robert5,Sharp Kirsten5

Affiliation:

1. U.S. Food and Drug Administration, Division of Testing and Applied Analytical Development, St. Louis, MO 63101

2. Visiting Scientist, Food and Drug Administration, Division of Testing and Applied Analytical Development (DTAAD), 1114 Market Street, Room 1002, St. Louis, MO 63101

3. Shanghai Institute for Drug Control, Republic of China. On technical assignment to DTAAD, St. Louis, MO

4. Senior Laboratory Officer, Institute of Science and Forensic Medicine, Singapore, On technical assignment to DTAAD, St. Louis, MO

5. Australian Therapeutic Goods Administration Woden, ACT 2606, Australia

Abstract

Abstract This paper describes a rapid, inexpensive thin-layer chromatographic (TLC) method that separates diethylene glycol (DEG) from glycerin and other glycols. Studies with collaborating laboratories of the World Health Organization have shown that about 6% DEG in glycerin and about 2% DEG in acetaminophen (paracetamol) elixirs may be detected by direct visual inspection of the developed TLC sheets. Staining the sheet permits detection of DEG at less than 0.1%. The method costs less than $1.00 per test and takes 20 min by visual inspection, longer when staining is required. The visual method can be performed without laboratory facilities by personnel having little previous training. Samples testing positive by the visual method can be submitted to a laboratory for confirmation and quantitation of DEG.

Publisher

Oxford University Press (OUP)

Subject

Pharmacology,Agronomy and Crop Science,Environmental Chemistry,Food Science,Analytical Chemistry

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