AOAC SPDS Meeting Book March 19 2015

DRAFT AOAC SMPR 2015.XXX; Version 4; December 1, 2014 1 Standard Method Performance Requirements for 2 Determining Alkaloids of Mitragyna speciosa 3 4 Intended Use: Reference method for GMP compliance and surveillance.

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1 Purpose

AOAC Standard Method Performance Requirements SM (SMPR) describe the minimum recommended performance characteristics to be used during the evaluation of a method. The evaluation may be an on-site verification, a single-laboratory validation, or a multi-site collaborative study. SMPRs are written and adopted by AOAC Stakeholder Panels composed of representatives from the industry, regulatory organizations, contract laboratories, test kit manufacturers, and academic institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their evaluation of validation study data for method being considered for Performance Tested Methods or AOAC Official Methods of Analysis , and can be used as acceptance criteria for verification at user laboratories. [Refer to Appendix F: Guidelines for Standard Method Performance Requirements , Official Methods of Analysis of AOAC INTERNATIONAL (2012) 19th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA.]

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2 Applicability

Methods must be able to determine mitragynine, 7-hydroxymitragynine, and other relevant indole alkaloids of Mitragyna speciosa , in a broad range of matrices including plant material, extracts, and finished products. Methods should be able to quantitate the analytes for which appropriate standards are available and account for interfering compounds.

3 Analytical Technique:

Any analytical technique(s) that measures the analytes of interest and meets the

following method performance requirements is/are acceptable.

4 Definitions :

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. 1

Dietary supplements .— Products intended for ingestion, containing at least one "dietary ingredient", and not represented as a conventional food or as a sole item of a meal or the diet. They are products intended to add (supplement) further nutritional value to the diet. Dietary supplements may be found in many forms such as tablets, capsules, softgels,

gelcaps, liquids, or powders.

7-hydroxymitragynine .— (α E ,2 S ,3 S ,7a S ,12b S )-3-Ethyl-1,2,3,4,6,7,7a,12b-octahydro-7a- hydroxy-8-methoxy-α-(methoxymethylene)indolo[2,3-a]quinolizine-2-acetic acid methyl

ester. CAS no. 174418-82-7. See figure 1 for molecular structure.

1 Federal Food Drug and Cosmetic Act §201(ff) [U.S.C. 321 (ff)