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2024年5月20日发(作者：二郎神孙悟空谁更厉害)
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 a preliminary 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 a greater degree of uniformity in their
application.” The list of USP Reference Standards that in 1936 comprised 6 items
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 a reference standard.
NOMENCLATURE
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