11 USP REFERENCE STANDARDS

11 USP REFERENCE STANDARDS美国药典对照品USP Reference Standards are highly characterized specimens of drug

11 USP REFERENCE STANDARDS 美国药典对照品 USP Reference Standards are highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators. They are explicitly required in many Pharmacopeial assays and tests and are provided solely for such use. Assessment of the suitability for use in other application(s) rests with the purchaser. AUTHORITY FOR ESTABLISHMENT AND RELEASE USP Reference Standards are established and released under the authority of the USPC Board of Trustees upon recommendation of the USP Reference Standards Expert Committee, which approves each lot as being suitable for use in its compendial applications. For some Reference Standards apreliminary review and approval is sought from other Expert Committees of the Council of Experts. The distribution of controlled substances is subject to the regulations and licensing provisions of the Drug Enforcement Administration of the Department of Justice. Industry Advisory Panels and other expert groups (such as Project Teams) may be assembled to advise USP on various aspects of the Reference Standards Program. HISTORY Future availability of the first USP Reference Standards was announced in 1926 (USP X) “… in order to facilitate the adoption of the biological assay standards of the Pharmacopoeia, and to provide agreater degree of uniformity in their application.” The list of USP Reference Standards that in 1936 comprised 6items has grown to almost 1650 in 2004, and the collection has tracked the progress in pharmaceutical sciences: The first vitamins (Cod Liver Oil) and the first enzyme (Pepsin) in 1936; the first sulfonamide (Sulfanilamide) and the first hormones (Insulin; Posterior Pituitary) in 1942; the first performance standards (Melting Point Standards) in 1947; the first penicillin (Penicillin G Sodium) in 1950; the first recombinant-DNA technology protein (Insulin Human) in 1985, etc. The continuous increase in the number of USP Reference Standards (over 100 new standards are being developed yearly) reflects not only the increase in the number of monographs and General Chapters, but also the development and extensive use of modern analytical methodology (such as chromatography, spectrophotometry, biological and biochemical assays, etc.) which require measurements relative to areference standard. NOMENCLATURE Standards designated as USP Reference Standards (USP RS) are, with afew exceptions, required for use in USP–NF monographs or General Chapters. The exceptions include current lots of USP and NF Reference Standards for which uses are no longer specified in the current USP or NF but for which sufficient demand remains (upon depletion of the current lots, future lots will be designated as Authentic Substances), Reference Standards specified in monographs developed by USP that are not intended for publication in the