USP reference standards are highly characterized samples of active pharmaceutical ingredients and impurities, food chemicals, and dietary supplements and their ingredients. Regulators and manufacturers use these standards to assess how products conform to specifications of identity, quality, purity and strength.
USP reference standards are specified in the monographs of the U.S. Pharmacopeia and National Formulary (USP–NF), USP’s flagship compendia of quality standards; the Food Chemicals Codex (for food ingredients), the Dietary Supplements Compendium, and the new Medicines Compendium. Drugs sold or manufactured in the United States are required by law to comply with standards published in the USP–NF, and these standards are enforceable by the Food and Drug Administration.
“USP relies on our volunteer experts who, with staff, set the standards, and on the manufacturers who donate the monographs and materials from which many of our standards are derived. Both are equally crucial in the standards-setting process, and I want to take this opportunity to thank all who understand the importance of public standards,” said Roger L. Williams, M.D., chief executive officer at USP.
USP distributes thousands of units of its reference standards every year to customers in more than 140 countries around the world.