11.3 Sources of Methodology

Samples are analyzed using compendium methods as applicable. Compendium methods take precedence over use of other methods. Methods contained in the Association of Official Analytical Chemists (AOAC), United States Pharmacopeia (USP), or National Formulary (NF) are considered compendia methods. If a compendium method is not found, the Center for Food Safety and Applied Nutrition (CFSAN) is consulted. Whether a method is compendia or non-compendia, it is to be validated with recovery and reproducibility studies, use of positive and negative controls, use of Standard Reference Material, or in-house quality assurance/quality control materials. If a product is labeled as USP, the correct USP analytical method is used for analysis.

ACNA routinely encounters products that have no official method for the particular matrix. Use of AOAC procedures with modifications, memos of analysis (in-house methods), and standard operating procedures with proper controls and CFSAN approval have been used over the years.