Abstract # A-41

Limit of Alcohol Test for Liquid OTC Drug Products by Headspace Gas Chromatography. J.E. Santos. BLT-DO, FDA, Baltimore, MD

Numerous liquid OTC drug products in the marketplace such as cough and cold preparations have adopted the term, ýAlcohol-FreeÌ, on their label. Absence of alcohol is very important to some individuals for personal, religious or medical reasons. However, alcohol may be inadvertently introduced in these products from added coloring and flavorings. A quantitative limit test for detecting trace levels of alcohol in liquid OTC drug products was developed by Baltimore Laboratory using headspace gas chromatography. One principal advantage of headspace analysis is that column contamination and chromatographic interference by non-volatile, high molecular weight compounds is avoided, unlike when the sample is injected directly on the column. This method has been published in 21 CFR Part 328, Federal Register, March 13, 1995, and has been officially recognized by FDA to employ for this test.