AOAC SMPR^® 2016.014: Standard Method Performance Requirements (SMPRs^®) for Identification and Quantitation of Non-Animal-Derived Proteins in Dietary Supplements

Intended Use: Reference Method for cGMP Compliance

AOAC SMPRs describe the minimum recommended performance characteristics to be used during the evaluation of a method. The evaluation may be an on-site verification, a single-laboratory validation, or a multi-site collaborative study. SMPRs are written and adopted by AOAC stakeholder panels composed of representatives from industry, regulatory organizations, contract laboratories, test kit manufacturers, and academic institutions. AOAC SMPRs are used by AOAC expert review panels in their evaluation of validation study data for methods being considered for Performance Tested Methods^SM or AOAC Official Methods of Analysis^SM, and can be used as acceptance criteria for verification at user laboratories.

Methods must identify and quantify one or more non-animal-derived protein(s) and their corresponding sources (Table 1) in the presence of potential adulterants (Table 2) in ingredients and finished dietary supplements.

Any analytical technique is acceptable.

Limit of detection (LOD).—Minimum concentration or mass of analyte that can be detected in a given matrix with no greater than 5% false-positive risk and 5% false-negative risk.

Limit of quantitation (LOQ).—Minimum concentration or mass of analyte in a given matrix that can be reported as a quantitative result.

Protein.—Naturally occurring and synthetic polypeptides having molecular weights greater than about 10 000 daltons (the limit is not precise) (IUPAC definition).

Recovery.—The fraction or percentage of spiked analyte that is recovered when the test sample is analyzed using the entire method.

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.—Standard deviation or relative standard deviation calculated from among-laboratory data. Expressed as the reproducibility standard deviation (SD_R); or % reproducibility relative standard deviation (%RSD_R).

See  Tables 3 and 4.

Suitable methods will include blank check samples, and check standards at the lowest point and midrange point of the analytical range.

Refer to Annex F: Development and Use of In-House Reference Materials in Appendix F: Guidelines for Standard Method Performance Requirements, Official Methods of Analysis of AOAC INTERNATIONAL (2019) 21st Ed., AOAC INTERNATIONAL, Rockville, MD, USA (https://dbpia.nl.go.kr/aoac-publications)

Data demonstrating method performance for the non-animal-derived proteins listed in Table 1 in the presence of the potential non-protein ingredients, including adulterants listed in Table 2, is recommended.

Appendix D: Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis, Official Methods of Analysis of AOAC INTERNATIONAL (2019) 21st Ed., AOAC INTERNATIONAL, Rockville, MD, USA (https://dbpia.nl.go.kr/aoac-publications)

Appendix F: Guidelines for Standard Method Performance Requirements, Official Methods of Analysis of AOAC INTERNATIONAL (2019) 21st Ed., AOAC INTERNATIONAL, Rockville, MD, USA (https://dbpia.nl.go.kr/aoac-publications)

Appendix K: Guidelines for Dietary Supplements and Botanicals, Official Methods of Analysis of AOAC INTERNATIONAL (2019) 21st Ed., AOAC INTERNATIONAL, Rockville, MD, USA (https://dbpia.nl.go.kr/aoac-publications)

None.

Approved by the AOAC Stakeholder Panel on Dietary Supplements (SPDS). Final Version Date: September 16, 2016.