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ARS Home » Northeast Area » Beltsville, Maryland (BHNRC) » Beltsville Human Nutrition Research Center » Food Composition and Methods Development Laboratory » Research » Publications at this Location » Publication #268390
Title: Guidelines for validation of botanical identification methods

Author
item Harnly, James - Jim
item APPLEQUIST, WENDY - Missouri Botanical Garden
item CASPAR, STEVEN - Us Food & Drug Administration (FDA)
item HARRINGTON, PETER - Ohio University
item HILL, NORMA - US Department Of Treasury
item LABUDDE, ROBERT - Least Cost Formulations, Ltd
item NEAL-KABABICK, JAMES - Flora Research Laboratories
item HARBAUGH-REYNAUD, DANICA - Authen Technologies
item ROMAN, MARK - Tampa Bay Analytical Laboratories
item ROMAN, SHAUNA - 4life Research
item SULLIVAN, DARRYL - Covance Laboratories
item TITLOW, BARRY - Compound Solutions, Inc
item WEHLING, PAUL - General Mills, Inc

Submitted to: Official Methods of Analysis of AOAC International
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 10/17/2011
Publication Date: 1/19/2012
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).