Abstract

Standard setting in the United States for fine chemicals used as drugs, food additives, laboratory reagents, and in the processing of semiconductors is described, as are reference materials for use in analytical procedures. The specifications and methods of test which comprise the standards are published on a regular basis, with interim supplements as necessary, in the United States Pharmacopeia (USP)-National Formulary (NF), the Food Chemicals Codex, Reagent Chemicals-ACS Specifications, and the Book of SEMI Standards. Many test methods, especially those in the USP and NF, require reference standards, available from the USP and the National Institute of Standards and Technology (NIST). The legal status of the USP, NF, FCC, and ACS Standards is discussed, as well as the impact on fine chemicals of the Federal Food, Drug, and Cosmetic Act requirements for Good Manufacturing Practice.