AOAC SMPR® 2018.

004 repeatability standard deviation (SDr); or % repeatability relative

standard deviation (%RSDr).
Reproducibility.—The standard deviation or relative standard
Standard Method Performance Requirements deviation calculated from among-laboratory data. Expressed as
(SMPRs®) for Determination of trans Resveratrol the reproducibility standard deviation (SDR); or % reproducibility
in Dietary Supplements and Dietary Ingredients relative standard deviation (%RSDR).
trans Resveratrol.—IUPAC name: 5-[(E)-2-(4-hydroxyphenyl)
ethenyl]benzene-1,3-diol. CAS No. 501-36-0. See Figure 1 for
chemical structure.
Intended Use: Quality Assurance and Compliance to
Current Good Manufacturing Practices 5 Method Performance Requirements

See Tables 2 and 3.

1 Purpose
6 System Suitability Tests and/or Analytical Quality Control
AOAC SMPRs describe the minimum recommended
performance characteristics to be used during the evaluation of a Suitable methods will include blank check samples, and check
method. The evaluation may be an on-site verification, a single- standards at the lowest point and midrange point of the analytical
range. A control sample must be included. The method must be
laboratory validation, or a multi-site collaborative study. SMPRs
specific for trans resveratrol.
are written and adopted by AOAC stakeholder panels composed
of representatives from the industry, regulatory organizations, 7 Reference Material(s)
contract laboratories, test kit manufacturers, and academic See Table 4.
institutions. AOAC SMPRs are used by AOAC expert review NIST Vaccinium spp. berries (freeze dried, extract, or oral
panels in their evaluation of validation study data for methods being dosage form) available in small amounts
considered for Performance Tested MethodsSM or AOAC Official Sigma CRM 76511
Methods of AnalysisSM, and can be used as acceptance criteria for Refer to Annex F: Development and Use of In-House Reference
verification at user laboratories. [Refer to Appendix F: Guidelines Materials in Appendix F: Guidelines for Standard Method
for Standard Method Performance Requirements, Official Methods Performance Requirements, 20th Ed. of the Official Methods of
of Analysis of AOAC INTERNATIONAL (2016) 20th Ed., AOAC Analysis of AOAC INTERNATIONAL (2016). Available at: http://
INTERNATIONAL, Rockville, MD, USA.] www.eoma.aoac.org/app_f.pdf
2 Applicability 8 Validation Guidance
The method must be specific for trans resveratrol quantitation in Appendix D: Guidelines for Collaborative Study Procedures to
the presence of the cis isomer in dietary supplements and dietary Validate Characteristics of a Method of Analysis, 20th Ed. of the
ingredients as listed in Table 1. Official Methods of Analysis of AOAC INTERNATIONAL (2016).
3 Analytical Technique Available at: http://www.eoma.aoac.org/app_d.pdf
Appendix K: Guidelines for Dietary Supplements and
Any analytical technique that meets the following method Botanicals, 20th Ed. of the Official Methods of Analysis of AOAC
performance requirements is acceptable. INTERNATIONAL (2016). Also at: J. AOAC Int. 95, 268(2012);
4 Definitions DOI: 10.5740/jaoacint.11-447 and available at: http://www.eoma.
aoac.org/app_k.pdf
Analytical range.—Includes all steps of the analytical procedure
9 Maximum Time-to-Determination
including sample preparation and further dilutions.
Dietary ingredient.—A vitamin; a mineral; an herb or other No maximum time.
botanical; an amino acid; a dietary substance for use by man
Approved by the AOAC Stakeholder Panel on Dietary Supplements
to supplement the diet by increasing total dietary intake; or a
(SPDS). Final Version Date: March 16, 2018.
concentrate, metabolite, constituent, extract, or combination of any
of the above dietary ingredients. {United States Federal Food Drug
and Cosmetic Act §201(ff) [U.S.C. 321 (ff)]}
Dietary supplement.—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, Table 1. Examples of dietary supplements and dietary
or powders. ingredients
Limit of quantitation (LOQ).—The minimum concentration Powders
or mass of analyte in a given matrix that can be reported as a
Tablets
quantitative result.
Raw materials.—Fresh, dried, or cut plant materials. Capsules
Recovery.—The fraction or percentage of spiked analyte that is Liquids
recovered when the test sample is analyzed using the entire method.
Softgels
Repeatability.—Variation arising when all efforts are made
to keep conditions constant by using the same instrument and Extracts
operator and repeating during a short time period. Expressed as the

© 2018 AOAC INTERNATIONAL

Figure 1. Chemical structure of resveratrol.

Table 2. Analytical range and LOQ based on matrix

Parameter
Analytical range, % (w/w)a 0.01–100
Limit of quantitation, % (w/w) 0.01
a
Range may be narrower depending on the analytical matrix.

Table 3. Method performance requirements as a function

of range
Acceptance criteria
Parameter <1% 1–50% >50–100%
Recovery, % 85–115 >97–103 98–102
RSDr, % ≤7.5 ≤5 ≤2
RSDR, % ≤10 ≤8 ≤3

Table 4. Reference material(s)

Source trans-Resveratrol cis-Resveratrol Resveratrol d-4
Alkemist Labs 4963S
Cresent Chemical Co. CA16811600
LGC CDX-00018089-500
European Pharmacopoeia Reference Standard Y000111194
Phytolab 89539
Santa Cruz Biotechnology sc-200808 sc-205254
Selleckhem S 1396
Sigma-Aldrich R5010
TLC Pharmceutical Standards R-079001 R-079002 R-079002
Toronto Research Chemicals R150000 R150005 R150001
USP 162105

© 2018 AOAC INTERNATIONAL