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DRAFT AOAC SMPR 2015.XXX; Version 4; December 3, 2014
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Method Name: Determining
Withanolide glycosides
and
aglycones
of
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Ashwagandha
(Withania somnifera)
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Intended Use
: Reference method for cGMP compliance.
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1.
Purpose
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AOAC SMPRs describe the minimum recommended performance characteristics to be used
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during the evaluation of a method. The evaluation may be an on-site verification, a single-
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laboratory validation, or a multi-site collaborative study. SMPRs are written and adopted by AOAC
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Stakeholder Panels composed of representatives from the industry, regulatory organizations,
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contract laboratories, test kit manufacturers, and academic institutions. AOAC SMPRs are used by
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AOAC Expert Review Panels in their evaluation of validation study data for method being considered
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for
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 INTERNATIONAL
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(2012) 19th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA.]
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2.
Applicability
:
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Methods shall quantitatively determine withanolide glycosides and aglycones of interest from
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biomass, extracts, and Ashwagandha-containing finished products.
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3.
Analytical Technique
:
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Any analytical technique(s) that measures the analytes of interest and meets the following method
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performance requirements is/are acceptable.
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4.
Definitions
:
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Dietary Ingredients
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A vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man
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to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent,
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extract, or combination of any of the above dietary ingredients.
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Dietary Supplements
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A product intended for ingestion that contains a "dietary ingredient" intended to add further
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nutritional value to (supplement) the diet. Dietary supplements may be found in many forms such as
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tablets, capsules, softgels, gelcaps, liquids, or powders.
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Limit of Quantitation (LOQ)
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The minimum concentration or mass of analyte in a given matrix that can be reported as a
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quantitative result.
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Federal Food Drug and Cosmetic Act
§201(ff) [U.S.C. 321 (ff)