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DRAFT AOAC Free Alpha Amino Acids SMPR, v7, 7 March 2017.
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Identification and Quantitation of Free Alpha Amino Acids in Dietary Ingredients and
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Supplements
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Intended Use
: Reference method for cGMP compliance.
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1.
Purpose:
AOAC SMPRs describe the minimum recommended performance characteristics to
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be used during the evaluation of a method. The evaluation may be an on-site verification, a
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single-laboratory validation, or a multi-site collaborative study. SMPRs are written and
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adopted by AOAC Stakeholder Panels composed of representatives from the industry,
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regulatory organizations, contract laboratories, test kit manufacturers, and academic
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institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their evaluation of
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validation study data for method being considered for
Performance Tested Methods
or AOAC
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Official Methods of Analysis
, and can be used as acceptance criteria for verification at user
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laboratories.
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2.
Applicability
:
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Methods must identify and quantify free alpha amino acids and related compounds (see
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Table 1) in dietary ingredients and finished dietary supplement products as listed in Table 2.
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May not address purity of ingredients. One or more methods may be needed to meet the
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entire range.
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3.
Analytical Technique
:
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Any analytical technique is acceptable.
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4.
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
. 132
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Dietary supplements
.— A product intended for ingestion that contains a “dietary ingredient”
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intended to add further nutritional value to (supplement) the diet. Dietary supplements may
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be found in many forms such as 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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Limit of Detection (LOD)
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The minimum concentration or mass of analyte that can be detected in a given matrix with
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no greater than 5% false-positive risk and 5% false-negative risk.
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Federal Food Drug and Cosmetic Act
§201(ff) [U.S.C. 321 (ff)