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DRAFT AOAC SMPR 2015.XXX; Version 4; December 1, 2014
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Standard Method Performance Requirements for
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Determining Alkaloids of
Mitragyna speciosa
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Intended Use: Reference method for GMP compliance and surveillance.
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Purpose
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AOAC
Standard Method Performance Requirements
SM
(SMPR) describe the minimum
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recommended performance characteristics to be used during the evaluation of a method.
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The evaluation may be an on-site verification, a single-laboratory validation, or a multi-site
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collaborative study. SMPRs are written and adopted by AOAC Stakeholder Panels composed
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of representatives from the industry, regulatory organizations, contract laboratories, test kit
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manufacturers, and academic institutions. AOAC SMPRs are used by AOAC Expert Review
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Panels in their evaluation of validation study data for method being considered for
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Performance Tested Methods
or AOAC
Official Methods of Analysis
, and can be used as
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acceptance criteria for verification at user laboratories. [Refer to Appendix F:
Guidelines for
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Standard Method Performance Requirements
,
Official Methods of Analysis of AOAC
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INTERNATIONAL
(2012) 19th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA.]
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Applicability
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Methods must be able to determine mitragynine, 7-hydroxymitragynine, and other
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relevant indole alkaloids of
Mitragyna speciosa
, in a broad range of matrices including plant
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material, extracts, and finished products. Methods should be able to quantitate the analytes
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for which appropriate standards are available and account for interfering compounds.
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Analytical Technique:
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Any analytical technique(s) that measures the analytes of interest and meets the
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following method performance requirements is/are acceptable.
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Definitions
:
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Dietary Ingredients
.— A vitamin; a mineral; an herb or other botanical; an amino acid; a
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dietary substance for use by man to supplement the diet by increasing total dietary intake;
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or a concentrate, metabolite, constituent, extract, or combination of any of the above
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dietary ingredients
. 137
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Dietary supplements
.— Products intended for ingestion, containing at least one "dietary
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ingredient", and not represented as a conventional food or as a sole item of a meal or the
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diet. They are products intended to add (supplement) further nutritional value to the diet.
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Dietary supplements may be found in many forms such as tablets, capsules, softgels,
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gelcaps, liquids, or powders.
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7-hydroxymitragynine
.— (α
E
,2
S
,3
S
,7a
S
,12b
S
)-3-Ethyl-1,2,3,4,6,7,7a,12b-octahydro-7a-
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hydroxy-8-methoxy-α-(methoxymethylene)indolo[2,3-a]quinolizine-2-acetic acid methyl
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ester. CAS no. 174418-82-7. See figure 1 for molecular structure.
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1
Federal Food Drug and Cosmetic Act
§201(ff) [U.S.C. 321 (ff)