pharmacopoeia

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pharmacopoeia

or

pharmocopeia

(fär'məkəpē`ə), authoritative publication designating the properties, action, use, dosage, and standards of strength and purity of drugs. It is compiled under the supervision of professional, usually governmental, authority, and all manufacture and dispensation of drugs and medications are required to conform to it. The first work of this kind, the Nuremburg Pharmacopoeia, was published in Germany in 1546. Similar volumes appeared from time to time in other cities, but there was a wide variation and the need became apparent to standardize such publications under national direction. The first pharmacopoeia published in the United States was compiled for army use and appeared in Philadelphia in 1778. The United States Pharmacopoeia (USP) was first published in 1820 following a convention of medical societies in Washington, D.C. This compendium became the legal standard in 1906 by enactment of the Food and Drug Act. The USP is brought up to date periodically by a committee of the U.S. Pharmacopoeial Convention; supplements are published as needed. Other nations have similar standardized pharmacopoeias.

Pharmacopoeia

 

a book containing descriptions of medicinal substances and providing standards for the purity and dosage of the substances. The first pharmacopoeia, the Ricettario Fiorentino (Florentine Book of Prescriptions), was issued in Florence in 1498. The first such work in Russia, the Pharmacopoea Rossica, was published in 1778.

The tenth, and current, edition of the official Soviet pharmacopoeia appeared in 1968. The Pharmacopoeia Committee is responsible for the compilation, revision, and reissue of the work, which has the force of law. The pharmacopoeia’s standards for medicinal products are mandatory for all the enterprises and establishments that prepare, store, use, and control these products. The pharmacopoeia includes descriptions of the methods of chemical, physicochemical, and biological analyses of drugs, information on reagents and indicators, a list of toxic drugs (list A), a list of highly potent drugs (list B), and tables of maximum single and daily doses for adults and children.

Many countries have national pharmacopoeias. The World Health Organization publishes Pharmacopoea Internationalis, which, however, lacks legal force.

pharmacopoeia

[‚fär·mə·kə′pē·ə]
(pharmacology)
A book containing a selected list of medicinal substances and their dosage forms, providing also a description and the standards for purity and strength for each.

pharmacopoeia

(sometimes US), pharmacopeia
an authoritative book containing a list of medicinal drugs with their uses, preparation, dosages, formulas, etc.
References in periodicals archive ?
Clearly, morphological and chemical tests, as prescribed by pharmacopoeial monographs, continue to form the basis for rigorous quality assurance of botanicals," Wohlmuth said.
Ayurvedic Pharmacopoeial Plant Drugs is not a recommended for the casual health collection for lay readers, but is a technical coverage that is the first to review all therapeutic sections of over four hundred fifty plant drugs in the first six volumes of the Ayurvedic Pharmacopoeia of India.
However, the conditions of stress testing are segregated for drug substances and products that are (a) if an active substance is described in an official pharmacopoeia and meet the pharmacopoeial parameters then no further data is required to address the degradation products if they are enlisted in section of impurities, (b) if an active substance is not mentioned in official pharmacopoeia, it is recommended to provide the relevant published data to support the proposed degradation pathways, and (c) if there is no scientific data available in literature then stress testing is required to generate the evidence of stability of an active drug substance and finished drug products where photostability should be an integral part of stress testing.
Pharmacopoeial monographs provide important information about the quality of a drug substance.
Martin et al, Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification, Pharmacopoeial Forum 39 (5) September October 2013 (Note there are no page numbers as this is only available on line at www.usp.org)
This means that these pharmacopoeial methods are not capable of detecting adulteration of ginkgo extract with free flavonol aglycones.
[2] United States Pharmacopoeia XXIII, National Formulary XVIII, United States Pharmacopoeial Convention, Rockville, Md, USA, 1995.
[23] USP-NF, The Official Compendia of Standards, The United State Pharmacopoeial Convention, Rockville, Md, USA, 2006.
[12] The United States Pharmacopoeia, USP 29-NF 24, the United States Pharmacopoeial Convention, Rockville, Md, USA, 2008.
also reported that the artesunate content of tablets sampled in Kumasi varied between 47.9% and 99.9% of the manufacturer's label claim and only 3 (17.6%) of the samples met the European Pharmacopoeial requirements for content of active ingredients.
Evaluation of the ScanRDI(R) as a rapid alternative to the pharmacopoeial sterility test method: comparison of the limits of detection.