SPDS Meeting Book

DRAFT AOAC SMPR 2015.XXX; Version 7; June 16, 2015. 1 2 Method Name: 3 Determination of Catechins, Methyl Xanthines, Theaflavins, and Theanines in Tea Dietary Ingredients And Supplements 4 5 Purpose: AOAC SMPR’s describe the minimum recommended performance characteristics to be 6 used during the evaluation of a method. The evaluation may be an on-site verification, a single- 7 laboratory validation, or a multi-site collaborative study. SMPRs are written and adopted by 8 AOAC Stakeholder Panels composed of representatives from the industry, regulatory 9 organizations, contract laboratories, test kit manufacturers, and academic institutions. AOAC 10 SMPRs are used by AOAC Expert Review Panels in their evaluation of validation study data for 11 method being considered for Performance Tested Methods or AOAC Official Methods of 12 Analysis , and can be used as acceptance criteria for verification at user laboratories. 1

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Approved by: Stakeholder Panel on Dietary Supplements (SPDS) 15 16 Intended Use : Quality control, routine testing and dispute resolution.

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1. Applicability :

Quantitative determination of catechins, methyl xanthenes, theaflavins and theanine in tea

dietary ingredients and supplements.

2. Analytical Technique :

Any analytical technique(s) that measures the analytes of interest and meets the following method performance requirements is/are acceptable. It is acceptable to have a different

analytical method for each class of analytes.

3. Definitions :

Catechins

Catechin, epicatechin, epigallocatechin, catechin gallate, epicatechin gallate, epigallocatechin gallate, and gallocatechin. Refer to table 3 for IUAC nomenclature and CAS

registry numbers. See figure 1 for chemical structures.

Dietary Ingredients

A vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients. 2

Dietary supplements

A product intended for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet. Dietary supplements may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.

1 Refer to Appendix F : Guidelines for Standard Method Performance Requirements in the 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). 2 United States Federal Food Drug and Cosmetic Act §201(ff) [U.S.C. 321 (ff)]

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