SPDS 09052014

DRAFT AOAC SMPR 2014.XXX; Version 4; July 14, 2014 (clean) 1 2 3 Method Name: Identification of PDE5 Inhibitors 4 5 Purpose: AOAC SMPRs describe the minimum recommended performance characteristics to be 6 used during the evaluation of a method. The evaluation may be an on-site verification, a single- 7 laboratory validation, or a multi-site collaborative study. SMPRs are written and adopted by 8 AOAC Stakeholder Panels composed of representatives from the industry, regulatory 9 organizations, contract laboratories, test kit manufacturers, and academic institutions. AOAC 10 SMPRs are used by AOAC Expert Review Panels in their evaluation of validation study data for 11 method being considered for Performance Tested Methods or AOAC Official Methods of Analysis , 12 and can be used as acceptance criteria for verification at user laboratories.

13 14 15 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

Approved by: Stakeholder Panel on Dietary Supplements (SPDS)

Final version date :

Effective date:

Intended Use : Reference method for dispute resolution.

1. Applicability :

Identification of PDE5 inhibitors in dietary ingredients and supplements.

2. Analytical Technique :

Any analytical technique(s) that identifies 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.

Identification Method

A method that is capable of identifying the PDE5 inhibitors listed in Annex II and providing at least class identification of other PDE5 inhibitors based on their structural similarity to the compounds listed in Annex II . A Supplemental List of Known PDE5 Inhibitors (as of July 2014) at the AOAC website (address and hyperlink to be inserted) provides an overview of currently known PDE5 inhibitors, for which analytical standards are available in the majority

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