Glycerine and diethylene glycol are similar in smell, taste, and appearance. This poses serious risks as diethylene glycol and ethylene glycol are unacceptable toxic substances used often to adulterate the more expensive glycerin. Glycerin USP should be tested in order to demonstrate the absence of these substances. In 1997, the US FDA advised all US medicine manufacturers to test all batches of glycerine for possible contamination of diethylene glycol, this followed an incident of 100 fatal poisonings recorded in Panama from a Chinese factory deliberately falsifying records in order to export cheaper medicines using diethylene glycerol.
As a result, the FDA published “Testing of Glycerin for Diethylene Glycol” in May of the same year, which sets standards to prevent contamination of drugs from these substances. The Glycerin USP Monograph was further revised after receiving feedbacks from several industry groups and concerned companies about related timing and technical issues. The revision was approved by the USP Excipient Monograph 1 Expert Committee and became official last May 1, 2009, in accordance with Section 9.06(c) of the Rules and Procedures of the Council of Experts. In the revised monograph, levels of diethylene glycol and ethylene glycol should not reach more than 0.10% for each upon using methanol as the diluent and a sensitive gas-liquid chromatographic with flame ionization detection test.
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