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Published: Thursday, November 2, 2017
AHPA has published a resource document that describes test methods that can be used to identify ethanol.
Dietary supplement operations are required to confirm the identity of non-dietary components used in their products and determine whether other applicable components’ specifications are met. To fulfil these requirements, manufacturers need to conduct appropriate tests or examinations or rely on certificates of analysis from suppliers of these components, provided that the criteria listed in 21 CFR 111.75(a)(2) are satisfied.
“This AHPA resource will be useful for companies that receive a clear liquid in a jug labeled ethanol,” said AHPA Chief Science Officer Maged Sharaf, Ph.D. “It will help them verify the identity of the liquid in order to satisfy dietary supplement manufacturing requirements enforced by the Food and Drug Administration.”
The document was developed with extensive input from AHPA members and will help AHPA members conduct appropriate testing to identify ethanol. It covers a number of physical, chemical, spectrometric and chromatographic methods for the identification of ethanol.
The document is not an exhaustive collection of test methods for ethanol and other methods not included in the document may be equally suitable.