2012 USP Dietary Supplements Compendium

Wednesday, 02 May, 2012



The 2012 USP Dietary Supplements Compendium provides unbiased, scientifically sound specifications on a host of dietary supplements and ingredients. It offers international dietary supplement manufacturers of all sizes a comprehensive resource for finding suitable, unbiased and scientifically sound analytical methods, and specifications for the identity, quality and purity of ingredients and products.

As raw materials used in dietary supplements are sourced from around the world and global manufacturing of finished products accelerates, a new resource now available can help manufacturers, suppliers, laboratories and regulatory agencies ensure the quality of these ingredients and products. Published by the US Pharmacopeial Convention (USP), the 2012 USP Dietary Supplements Compendium (DSC) can assist dietary supplement manufacturers in developing quality specifications, testing new products, qualifying raw materials and protecting their overall supply chains.

In addition to analytical methods and specifications, DSC includes essential information such as the regulatory framework for dietary supplements, industry guidance documents and tables of dietary intake levels. Other practical features for manufacturers, ingredient suppliers, contract laboratories and regulatory agencies include checklists for Good Manufacturing Practices audits used by the USP Dietary Supplement Verification Program; Good Agricultural Practices from the American Herbal Products Association; and US Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidelines on appropriate labelling for dietary supplements. DSC standards also can be used as the basis for buyer-supplier relationships and contractual agreements regarding expected quality of dietary supplement components.

Now offered in a two-volume set, DSC contains more than 550 monographs for finished products, dietary ingredients and other components common to dietary supplement manufacturing, derived from the United States Pharmacopeia-National Formulary (USP 35-NF 30) and Food Chemical Codex (FCC), Eighth Edition. The 2012 DSC includes 64 new dietary supplement monographs and approximately 150 excipient monographs.

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