Pharmacopoeia
A book published usually under the jurisdiction of the
government and containing a list of drugs, their formulas, methods for making
medicinal preparations, requirements and tests for their strength and purity,
and other related information. Descriptions of preparations are called
monographs.
Pharmacopoeia: the word derives from the ancient Greek
φαρμακοποιΐα (pharmakopoiia), from φαρμακο- (pharmako-) ″drug″, followed by the
verb-stem ποι- (poi-) ″make″ and finally the abstract noun ending -ια (-ia).
These three elements together can be rendered as ″drug-mak-ing″ or ″to make a
drug″. A pharmacopoeia, pharmacopeia, or pharmacopoea, in its modern sense, is
a legally binding collection, prepared by a national or regional authority, of
standards and quality specifications for medicines used in that country or
region. A quality specification is composed of a set of appropriate tests that
will confirm the identity and purity of the product, ascertain the strength (or
amount) of the active substance and, when needed, its performance
characteristics. Reference substances, i.e. highly-characterized, physical
specimens, are used in testing to help ensure the quality, such as identity,
strength and purity, of medicines. The texts cover pharmaceutical starting
materials, excipients, intermediates and finished pharmaceutical products
(FPPs). General requirements may also be given in the pharmacopoeia on
important subjects related to medicines quality, such as analytical methods,
microbiological purity, dissolution testing, stability, etc.
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