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 over 200-year old United States Pharmacopeial Convention (usually also called the USP), a nonprofi ...
and the
European Pharmacopoeia.
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)
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Pharmacopoeia
A pharmacopoeia, pharmacopeia, or pharmacopoea (or the typographically obsolete rendering, ''pharmacopœia''), meaning "drug-making", in its modern technical sense, is a reference work containing directions for the identification of compound med ...
References
External links
European Pharmacopoeia
United States PharmacopeiaReference Standards of the European Pharmacopoeia Drugs
Health standards
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