A drug reference standard or pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.
Pharmacopoeial reference standards
Pharmacopoeial reference standards are a subset of pharmaceutical reference standards. They are established for the intended use described in
pharmacopeial texts (monographs and general chapters). Pharmacopeial reference standards are available from various pharmacopoeias such as
United States Pharmacopeia
The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that ...
and the
European Pharmacopoeia
The ''European Pharmacopoeia'' (''Pharmacopoeia Europaea'', ''Ph. Eur.'') is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the su ...
.
Where pharmacopoeial tests or assays call for the use of a pharmacopoeial reference standard, only those results obtained using the specified pharmacopoeial reference standard are conclusive.
See also
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Standard (metrology)
In metrology (the science of measurement), a standard (or etalon) is an object, system, or experiment that bears a defined relationship to a unit of measurement of a physical quantity. Standards are the fundamental reference for a system of weigh ...
*
Pharmacopoeia
A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography ''pharmacopœia'', meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by ...
References
External links
European Pharmacopoeia
United States PharmacopeiaReference Standards of the European PharmacopoeiaReference Standards of the United States PharmacopeiaHorizon Discovery Reference MaterialLGC StandardsChiron ASSynThinkClearsynthEDQM Reference Standards Training Resources
Drugs
Health standards
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