DRAFT AOAC SMPR 2014.XXX; Version 4; July 14, 2014 (clean)
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Method Name: Identification of PDE5 Inhibitors
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Purpose:
AOAC SMPRs describe the minimum recommended performance characteristics to be
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used during the evaluation of a method. The evaluation may be an on-site verification, a single-
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laboratory validation, or a multi-site collaborative study. SMPRs are written and adopted by
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AOAC Stakeholder Panels composed of representatives from the industry, regulatory
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organizations, contract laboratories, test kit manufacturers, and academic institutions. AOAC
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SMPRs are used by AOAC Expert Review Panels in their evaluation of validation study data for
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method being considered for
Performance Tested Methods
or AOAC
Official Methods of Analysis
,
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and can be used as acceptance criteria for verification at user laboratories.
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Approved by:
Stakeholder Panel on Dietary Supplements (SPDS)
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Final version date
:
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Effective date:
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Intended Use
: Reference method for dispute resolution.
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1.
Applicability
:
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Identification of PDE5 inhibitors in dietary ingredients and supplements.
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2.
Analytical Technique
:
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Any analytical technique(s) that identifies the analytes of interest and meets the following
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method performance requirements is/are acceptable.
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3.
Definitions
:
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Dietary Ingredients
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A vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use
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by man to supplement the diet by increasing total dietary intake; or a concentrate,
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metabolite, constituent, extract, or combination of any of the above dietary ingredients.
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Dietary supplements
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A product intended for ingestion that contains a "dietary ingredient" intended to add further
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nutritional value to (supplement) the diet. Dietary supplements may be found in many forms
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such as tablets, capsules, softgels, gelcaps, liquids, or powders.
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Identification Method
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A method that is capable of identifying the PDE5 inhibitors listed in Annex II and providing at
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least class identification of other PDE5 inhibitors based on their structural similarity to the
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compounds listed in Annex II . A
Supplemental List of Known PDE5 Inhibitors
(as of July
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2014) at the AOAC website (address and hyperlink to be inserted) provides an overview of
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currently known PDE5 inhibitors, for which analytical standards are available in the majority
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FDA.
