Appendix K: Guidelines for Dietary Supplements and …

2019 AOAC INTERNATIONALThis Appendix contains three complementary documents for the validation of Dietary Supplements and botanical methods:Part I: AOAC Guidelines for Single-Laboratory Validation of Chemical Methods for Dietary Supplements and BotanicalsPart II: AOAC Guidelines for Validation of Botanical Identification MethodsPart III: Probability of Identification: A Statistical Model for the Validation of Qualitative Botanical Identification MethodsPART I AOAC Guidelines for Single-Laboratory Validation of Chemical Methods for Dietary Supplements and BotanicalsContents 1 Method of Performance Characteristics of a Method of Analysis 2 Single-Laboratory Validation Preparation of the Laboratory Method of Analysis or Reference Ruggedness Specific Variablesa. Analyte Additionb. Reextraction of the Extracted Residuec. Comparison with Different Solventsd. Comparison with Results from a Different Proceduree. System Suitability Checks 3 Performance Applicability (Scope) External Standard Internal Standard Standard Addition Reliability Repeatability Precision (sr, RSDr) Measurement Reproducibility Precision (sR, RSDR) Intermediate Limit of Reporting Low-Level Dichotomous Control Injection Duplicate Confirmation of Stability of the Analyte 4 Report (as applicable) Applicability (Scope) Results of Identificatio

laboratory that merely requires verification of the capability of that laboratory to achieve the published performance characteristics. The opposite extreme is the initial presentation of a new method or the initial application of an established method to a new matrix or application. Methods that are developed in response to a continued

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