Pharmacopoeia Flashcards
Derived from Greek word___meaning drug and
____ meaning to make.
pharmakon and poiea
purpose
A legal and official book issued by recognized authorities
appointed by the Government of each country.
content
It comprises a list of pharmaceutical substances, formulae,
descriptions, and standards.
definition
A book containing directions for identifying compound
medicines published by government or medical authorities.
list
British European Indian
International United States
BRITISH PHARMACOPOEIA
First Edition-Published in 1864.
Content-Two sections: Materia Medica and Preparations &
Compounds.
Early Editions-Published in 1867, 1898,
1914, and 1953.
Eighth Edition-Titles of drugs and
preparations were in
English instead of Latin,
using the metric system.
Current Publication-Published annually.
BRITISH PHARMACOPOEIA
2007-2009 Editions
Published in six volumes: I to VI.
Content:
Volumes I & II contain medicinal substances, while Volumes
III-VI cover formulated preparations, blood products
UNITED STATES
PHARMACOPOEIA
First Edition-Published on December 15,
1820, in both Latin and
English.
Early Publication
Frequency-Published at ten-year
intervals from 1820 to
1942.
Later Publication
Frequency-Published at five-year
intervals from 1942 to
2000.
Current Publication-Published annually since
2002.
EUROPEAN
PHARMACOPOEIA
Commission Establishment:
The European Pharmacopeia Commission began working in 1964 to prepare the European
Pharmacopeia.
Editions: Editions 1-8 have been published since 1967, each with
a specific publication and validity date.
Monographs must be?
Comprehensive
Standardized
Detailed
Substance Specific
EDQM Collaboration
Public Involvement
The Pharmacopoeia and other
relevant documents on the state of
work must be consulted to see if
______ on similar substances
exist or are being elaborated.
monographs
If monographs or draftson similar
substances already exist, it is
important to ensure that the
monograph to be elaborated follows
the ____unless there are
good reasons to deviate
same approach
Substances that are to be described
in a monograph may be members of
a group of very____
similar substances
Essential to gather
information on the
substance in question,
including origin,
composition, preparation
methods, and potential
crystalline forms.
Information
Gathering (M)
Investigate whether
different enantiomers,
racemates, or mixtures of
enantiomers are available.
Enantiomer
Consideration (M)
Determine whether different hydrates or entities (acid, base,
salt) are available.
Hydrate and Entity Consideration (M)
Consult the Pharmacopoeia
and other relevant
documents to see if
monographs on similar
substances exist or are
being elaborated.
Existing Monograph
Consultation (M)
Ensure the monograph
follows the same approach
as existing monographs
unless there are compelling
reasons to deviate, e.g.,
developments in analytical
techniques.
Consistency and
Deviation (M)
Consider substances as part of a family group, especially for
excipients like macrogols.
Family groups (M)
TITLE
INN Use
Use the International
Nonproprietary Name (INN)
established by the World
Health Organization where
available.
Hydration and
Anion/Cation
Indication
Supplement with the name
of the anion or cation,
“hydrate,” “dihydrate,”
“hydrated,” or “anhydrous”
as appropriate.
Veterinary Use
Include “for veterinary use” in the title if the substance is used in
approved medicinal products for veterinary use only in Member
States.
DEFINITION
Chemical Structure
Ascertain the chemical structure with precision to establish
the exact graphic formula, empirical formula, and relative
molecular mass.
Isomer and Optical Isomer Specification
Specify which isomer is used or state that the product is a
mixture of isomers. For an optical isomer, specify the
absolute configuration.
DEFINITION
Hydration and Solvation
Distinguish clearly between well-defined hydrates and solvates
and products with variable quantities of solvent(s).
COMBINATIONS
Chemical Combinations
Specify each component of the combination or mixture, with its
chemical structure and proportion present.
CONTENT
Impurities
The substance described in
a monograph is never
wholly pure, but contains a
limited proportion of
impurities.
Assay Limits
Assay limits are specified
between which the content
must fall, taking into
account the precision of the
method and acceptable
purity.
Assay Limit Expression
Assay limits are normally expressed with reference to the dried
or anhydrous substance.
CONTENT
Non-Specific Assay
For a non-specific assay, the assay limits are usually
99.0-101.0% (unless otherwise justified).
Specific Assay
For a specific assay using a separation technique, the
upper assay limit is normally 102.0%, and the lower
assay limit takes into account any impurities present.
CHARACTERISTICS
Appearance
This description normally
embraces color and physical form.
Solubility
Solvents quoted are normally
confined to water, an alcohol, and
a lipophilic solvent. Solubility in
other solvents may also be
mentioned.
