SPDS eBook March 2017

DRAFT AOAC Free Alpha Amino Acids SMPR, v7, 7 March 2017. 1 2 Identification and Quantitation of Free Alpha Amino Acids in Dietary Ingredients and 3 Supplements 4 5 Intended Use : Reference method for cGMP compliance. 6 7 1. Purpose: AOAC SMPRs describe the minimum recommended performance characteristics to 8 be used during the evaluation of a method. The evaluation may be an on-site verification, a 9 single-laboratory validation, or a multi-site collaborative study. SMPRs are written and 10 adopted by AOAC Stakeholder Panels composed of representatives from the industry, 11 regulatory organizations, contract laboratories, test kit manufacturers, and academic 12 institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their evaluation of 13 validation study data for method being considered for Performance Tested Methods or AOAC 14 Official Methods of Analysis , and can be used as acceptance criteria for verification at user 15 laboratories.

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2. Applicability :

Methods must identify and quantify free alpha amino acids and related compounds (see Table 1) in dietary ingredients and finished dietary supplement products as listed in Table 2. May not address purity of ingredients. One or more methods may be needed to meet the

entire range.

3. Analytical Technique :

Any analytical technique is 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 .— 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.

Limit of Quantitation (LOQ)

The minimum concentration or mass of analyte in a given matrix that can be reported as a

quantitative result.

Limit of Detection (LOD)

The minimum concentration or mass of analyte that can be detected in a given matrix with

no greater than 5% false-positive risk and 5% false-negative risk.

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