DRAFT AOAC SMPR 2015.XXX; Version 4; June 12, 2015
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Method Name:
Determination of Vitamin D in Dietary Supplement Consumer Products
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and Raw Materials
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Approved by:
Stakeholder Panel on Dietary Supplements
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Intended Use
:
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1.
Applicability
:
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The method will separate and accurately quantitate vitamin D
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(ergocalciferol), vitamin D
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(cholecalciferol), and their previtamin d and hydroxy forms in dietary supplement consumer
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products and the raw materials used to formulate these products.
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2.
Analytical Technique
:
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Any analytical technique that meets the following method performance requirements is
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acceptable.
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3.
Definitions
:
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Dietary ingredients
.— A vitamin; a mineral; an herb or other botanical; an amino acid; a
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dietary substance for use by man to supplement the diet by increasing total dietary intake;
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or a concentrate, metabolite, constituent, extract, or combination of any of the above
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dietary ingredients. {United States Federal Food Drug and Cosmetic Act §201(ff) [U.S.C. 321
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(ff)]}
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Dietary supplements.— A product intended for ingestion that contains a “dietary
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ingredient” intended to add further nutritional value to (supplement) the diet. Dietary
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supplements may be found in many forms such as tablets, capsules, softgels, gelcaps,
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liquids, or powders.
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Limit of Quantitation (LOQ) .— The minimum concentration or mass of analyte in a given
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matrix that can be reported as a quantitative result
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Repeatability .— Variation arising when all efforts are made to keep conditions constant by
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using the same instrument and operator and repeating during a short time period.
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Expressed as the repeatability standard deviation (SD
r
); or % repeatability relative standard
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deviation (%RSD
r
).
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Reproducibility.— The standard deviation or relative standard deviation calculated from
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among-laboratory data. Expressed as the reproducibility relative standard deviation (SD
R
); or
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% reproducibility relative standard deviation (% RSD
R
).
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Recovery.— The fraction or percentage of spiked analyte that is recovered when the test
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sample is analyzed using the entire method.
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