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The United States Pharmacopeia is a compendium of quality control tests for drugs and excipients to be introduced into a medicinal formulation. It is published every year [1] by the United States Pharmacopeial Convention, and includes methods for, amongst others, identification, assay, and purity determination of a drug substance or excipient. It forms the basis of enforcement actions by the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration and is the official pharmacopoeia of the United States and many other nations. Therefore, in case of a dispute, those methods which are stated in the USP will be the legally binding ones.
Within the field the compendium is referred to simply as the USP. The initials USP are affixed to materials' names to indicate that they conform to the specifications in the USP and may be used medicinally.
See also
- Pill splitting, for a discussion of USP standards concerning uniformity of dosage
- The International Pharmacopoeia
- European Pharmacopoeia
- MedlinePlus, for information of specific drugs
Notes and references
- ^ United States Pharmacopeia: National Formulary (USP–NF)
JPE/JP - Japanese Pharmacopoeia
External links
Wikipedia content modification information:
- This page was last modified on 26 May 2008, at 00:14.
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