SPDS Draft SMPR - Free Amino Acid v6.1.docx

DRAFT AOAC Free Alpha Amino Acids SMPR, v6.1, 30 November 2016.  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  8 to be used during the evaluation of a method.  The evaluation may be an on‐site  9 verification, a single‐laboratory validation, or a multi‐site collaborative study.  SMPRs are  10 written and adopted by AOAC Stakeholder Panels composed of representatives from the  11 industry, regulatory organizations, contract laboratories, test kit manufacturers, and  12 academic institutions.  AOAC SMPRs are used by AOAC Expert Review Panels in their  13 evaluation of validation study data for method being considered for  Performance Tested  14 Methods  or AOAC Official Methods of Analysis , and can be used as acceptance criteria for  15 verification at user laboratories. 

16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47

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)

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