SPDS 09052014

DRAFT AOAC SMPR 2014.XXX; Version 5; July 21, 2014 1 2 Method Name: Determination of PDE5 Inhibitors 3 4 Purpose: AOAC SMPRs describe the minimum recommended performance characteristics to be used 5 during the evaluation of a method. The evaluation may be an on-site verification, a single-laboratory 6 validation, or a multi-site collaborative study. SMPRs are written and adopted by AOAC Stakeholder 7 Panels composed of representatives from the industry, regulatory organizations, contract laboratories, 8 test kit manufacturers, and academic institutions. AOAC SMPRs are used by AOAC Expert Review Panels 9 in their evaluation of validation study data for method being considered for Performance Tested 10 Methods or AOAC Official Methods of Analysis , and can be used as acceptance criteria for verification at 11 user laboratories.

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Approved by: Stakeholder Panel on Dietary Supplements (SPDS)

Final version date :

Effective date:

Intended Use : Reference method for dispute resolution.

1. Applicability :

Quantitative method for PDE5 inhibitors in dietary ingredients and supplements for use in testing

laboratories by trained technicians.

2. Analytical Technique :

Any analytical technique(s) that measures the analytes of interest and meets the following method

performance requirements is/are acceptable.

3. 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.

1 New Dietary Ingredients in Dietary Supplements - Background for Industry ; FDA.