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DRAFT AOAC SMPR 2016.XXX; Version 5; November 16, 2016
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Method Name: Quantitation of Select Nonvolatile Ginger Constituents
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Intended Use
:
Control of incoming ingredients and finished products
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1.
Purpose
: AOAC SMPRs describe the minimum recommended performance characteristics to be used
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during the evaluation of a method. The evaluation may be an on‐site verification, a single‐laboratory
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validation, or a multi‐site collaborative study. SMPRs are written and adopted by AOAC Stakeholder
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Panels composed of representatives from the industry, regulatory organizations, contract laboratories,
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test kit manufacturers, and academic institutions. AOAC SMPRs are used by AOAC Expert Review
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Panels in their evaluation of validation study data for method being considered for
Performance
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Tested Methods
or AOAC
Official Methods of Analysis
, and can be used as acceptance criteria for
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verification at user laboratories.
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2.
Applicability
:
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The method is
required
to quantitate [6]‐, [8]‐ and [10]‐gingerols and [6]‐shogaol in the dietary
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ingredients and dietary supplements listed in Table 2. It is desirable, but
optional
, for the method to
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quantitate: [8]‐ and [10]‐shogaols, [6]‐, [8]‐ and [10]‐paradols, [6]‐ and [10]‐gingerdiols, [6]‐, [8]‐ and
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[10]‐gingerdiones, and zingerone.
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3.
Analytical Technique
:
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Any technique that quantitates the analytes defined in the Applicability statement and satisfies the
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method performance requirements set forth in this SMPR.
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4.
Definitions
:
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Analytes
— Refer to Table 4 for the list of analytes, their chemical attributes and identifiers. Refer to
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Figure 1 for the chemical structures.
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Dietary Ingredient
— A vitamin; a mineral; an herb or other botanical; an amino acid; a dietary
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substance for use 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
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ingredients are conventionally presented as powders or liquids.
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Dietary supplement
— A product containing a dietary ingredient intended for ingestion to supplement
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the diet. Dietary supplements containing dietary ingredients are commonly marketed as tablets,
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capsules, softgels, tinctures, or other finished dosage forms.
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Limit of Quantitation (LOQ)
— The minimum content of analyte in a given matrix that can be reliably
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and precisely quantitated in agreement with the requirements set forth in this SMPR.
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Repeatability
— Statistical variation in the analytical outcome arising when the maximum control over
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the analytical methodology is afforded. Replicate analyses are performed by the same operator within
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a short time period using the same instrumentation. Expressed as the
repeatability standard
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deviation
(SD
r
) or
% repeatability relative standard deviation
(%RSD
r
).
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Federal Food Drug and Cosmetic Act
§201(ff) [U.S.C. 321 (ff)