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United States Department of Agriculture

Agricultural Research Service

Research Project: FINGERPRINTING AND PROFILING METHODS FOR CHARACTERIZATION OF FOODS AND DIETARY SUPPLEMENTS

Location: Food Composition and Methods Development Lab

Title: Guidelines for validation of botanical identification methods

Authors
item HARNLY, JAMES
item Applequist, Wendy -
item Caspar, Steven -
item Harrington, Peter -
item Hill, Norma -
item Labudde, Robert -
item Neal-Kababick, James -
item Harbaugh-Reynaud, Danica -
item Roman, Mark -
item Roman, Shauna -
item Sullivan, Darryl -
item Titlow, Barry -
item Wehling, Paul -

Submitted to: Official Methods of Analysis of AOAC International
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: October 17, 2011
Publication Date: January 19, 2012
Citation: Harnly, J.M., Applequist, W., Caspar, S., Harrington, P., Hill, N., Labudde, R., Neal-Kababick, J., Harbaugh-Reynaud, D., Roman, M., Roman, S., Sullivan, D., Titlow, B., Wehling, P. 2012. Guidelines for validation of botanical identification methods. Official Methods of Analysis of AOAC International. 95:268-272.

Interpretive Summary: Identification of botanical materials, especially botanical dietary supplements, has become a major concern in light of the tremendous growth of the market. Adulteration, intentional and accidental, is common. The FDA has recently issued current good manufacturing procedures (cGMPs) that require identification of all botanical ingredients in a product. This has created an even greater demand for validated analytical methods for botanical identification. AOAC INTERNATIIONAL is the U.S. scientific body responsible for validation of analytical methods. They assembled an expert review panel to draft guidelines to be used for validating botanical identification methods. These guidelines establish basic concepts regarding botanical identification. The method can be regarded as a black box that returns a binary result: 1=yes this is the material, or 0=no this is not the material. It must discriminate between specified target and non-target materials, it must discriminate between materials with acceptable and unacceptable purity, and it must be characterized with respect to the probability-of-identification curve that shows the concentration-dependent transition from 1 (yes) to 0 (no). These guidelines will be used by all developers of botanical identification methods.

Technical Abstract: Identification of botanical materials, especially botanical dietary supplements, has become a major concern in light of the tremendous growth of the market. Adulteration, intentional and accidental, is common. The FDA has recently issued current good manufacturing procedures (cGMPs) that require identification of all botanical ingredients in a product. This has created an even greater demand for validated analytical methods for botanical identification. AOAC INTERNATIIONAL is the U.S. scientific body responsible for validation of analytical methods. They assembled an expert review panel to draft guidelines to be used for validating botanical identification methods. These guidelines establish basic concepts regarding botanical identification. The method can be regarded as a black box that returns a binary result: 1=yes this is the material, or 0=no this is not the material. It must discriminate between specified target and non-target materials, it must discriminate between materials with acceptable and unacceptable purity, and it must be characterized with respect to the probability-of-identification (POI) curve that shows the concentration-dependent transition from 1 (yes) to 0 (no).

Last Modified: 8/19/2014
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