the Stakeholder Panel on Dietary Supplements

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Limit of Quantitation (LOQ) .— The minimum concentration or mass of analyte in a given

matrix that can be reported as a quantitative result

Raw Materials: Fresh, dried, or cut plant material.

Repeatability .— Variation arising when all efforts are made to keep conditions constant by using the same instrument and operator and repeating during a short time period.

Expressed as the repeatability standard deviation (SD r

); or % repeatability relative standard

deviation (%RSD r ).

Reproducibility .— The standard deviation or relative standard deviation calculated from among-laboratory data. Expressed as the reproducibility relative standard deviation (SD R );

or % reproducibility relative standard deviation (% RSD R ).

Recovery .— The fraction or percentage of spiked analyte that is recovered when the test

sample is analyzed using the entire method.

5. Method Performance Requirements :

See tables 4 and 5.

6. System suitability tests and/or analytical quality control:

Suitable methods will include blank check samples, and check standards at the lowest point and midrange point of the analytical range. A control sample must be included.

7. Reference Material(s):

See table 2 and 7 for a list and sources of reference and testing materials.

Refer to Annex F: Development and Use of In-House Reference Materials in Appendix F: Guidelines for Standard Method Performance Requirements , 20 th Edition of the AOAC

INTERNATIONAL Official Methods of Analysis (2016). Available at:

http://www.eoma.aoac.org/app_f.pdf

8. Validation Guidance :

All target analytes and all claimed matrixes listed in Table 1, 2 and 3 shall be evaluated. Data for at least one analyte per claimed matrix/plant is acceptable provided that all analytes and

claimed matrices/plants are represented in the complete evaluation.

Appendix D: Guidelines for Collaborative Study Procedures tT o Validate Characteristics of a Method of Analysis; 20 h Edition of the AOAC INTERNATIONAL Official Methods of Analysis

(2016). Available at: http://www.eoma.aoac.org/app_d.pdf

Appendix K: Guidelines for Dietary Supplements and Botanicals 20 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Also at: . AOAC Int. 95, 268(2016); DOI: 10.5740/jaoacint.11-447 and available at: http://www.eoma.aoac.org/app_k.pdf

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8. Maximum Time-To-Determination: No maximum time.