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Pharmacopoeias
(from the word φαρµακοποιία)
play important role
JAMASOFT_2014-2015
as the basic document
basic document of
the pharmaceutical
legislation in all branches
of drugs.
The term Pharmacopoeia
is not new.
The idea of a pharmacopoeia with official status, to be followed by all,
originated in Florence.
The Nuovo Receptario,
JAMASOFT_2014-2015
The idea of a pharmacopoeia
with official status, to be followed by all
pharmacists and physicians, in all questions
in all questions
concerning drugs
concerning drugs,
JAMASOFT_2014-2015
concerning drugs
concerning drugs,
originated in Florence. The Nuovo
Receptario, originally written in Italian, was
published and became the legal standard for
the city-state in 1498.
Pharmacopoeia
is a book containing directions
book containing directions for the
identification of samples and the
JAMASOFT_2014-2015
identification of samples and the
preparation of compound-medicines, and
published by the authority of a government
published by the authority of a government
or a medical or pharmaceutical society.
Pharmacopoeia
with other words:
is a book describing drugs, chemicals, and
JAMASOFT_2014-2015
is a book describing drugs, chemicals, and
medicinal preparations,
which is issued by an officially recognized
authority and serves as a standard.
serves as a standard.
The purpose of a Pharmacopoeia is to:
1. Select the best, established
drugs (those "the utility of
which is most fully established
JAMASOFT_2014-2015
which is most fully established
and best understood").
The purpose of a Pharmacopoeia is to:
2. Set standards
standards of
of pharmaceutical
pharmaceutical
quality
quality ("form from them
JAMASOFT_2014-2015
quality
quality ("form from them
preparations and compositions in
which their powers may be exerted
to the greatest advantage").
The purpose of a Pharmacopoeia is to:
3. Name them ("distinguish those
articles by convenient and definite
JAMASOFT_2014-2015
articles by convenient and definite
names, such as may prevent
trouble or uncertainty in the
intercourse of physicians and
pharmacists").
The purpose of a Pharmacopoeia is to:
4. Encourage their use ("the value of a
Pharmacopoeia depends upon the
fidelity with which it conforms to the
best state of medical knowledge of the
best state of medical knowledge of the
day
day. Its usefulness depends upon the
JAMASOFT_2014-2015
day
day. Its usefulness depends upon the
sanction it receives from the medical
community and the public; and the
extent to which it governs the language
and practice of those for whose use it is
intended).
Pharmacopoeias are recognized as
the most authoritative sources of
information on drug standards.
JAMASOFT_2014-2015
The descriptive information
descriptive information about each
about each
drug includes
drug includes:
formulas, standards of purity and nomenclature,
efficacy, and usually dosage, the official standards
of strength, quality, purity, packaging, and
labeling for drug products.
In each pharmacopoeia there are
PHARMACOPOEIAL MONOGRAPHS.
JAMASOFT_2014-2015
The pharmacopoeia
The pharmacopoeia
is mostly composed by some
volumes.
JAMASOFT_2014-2015
volumes.
Each volume is updated
regularly with supplements.
Pharmacopeias
Pharmacopeias at present
at present
1. National (e.g. Slovak Pharmacopoeia,
Greek Pharmacopoeia, ...)
2. Regional and subregional (e.g. European
JAMASOFT_2014-2015
2. Regional and subregional (e.g. European
Pharmacopoeia),
3. International (e.g. International
Pharmacopoeia)
Some world
world-
-renowned
renowned
pharmacopoeias
pharmacopoeias:
•
• THE BRITISH PHARMACOPOEIA
THE BRITISH PHARMACOPOEIA
(B.P.)
(B.P.)
•
• THE EUROPEAN PHARMACOPOEIA
THE EUROPEAN PHARMACOPOEIA
JAMASOFT_2014-2015
•
• THE EUROPEAN PHARMACOPOEIA
THE EUROPEAN PHARMACOPOEIA
•
• THE INTERNATIONAL
THE INTERNATIONAL
PHARMACOPOEIA
PHARMACOPOEIA
•
• THE UNITED STATES
THE UNITED STATES
PHARMACOPOEIA (USP)
PHARMACOPOEIA (USP)-
- THE
THE
NATIONAL FORMULARY (NF )
NATIONAL FORMULARY (NF )
THE BRITISH PHARMACOPOEIA
(B.P.)
Pharmacopoea Britannica (P.B.)
has been a source of reference on the
quality of substances, preparations and
JAMASOFT_2014-2015
quality of substances, preparations and
articles used in medicine and pharmacy
for over 120 years.
The British Pharmacopoeia 2007
JAMASOFT_2014-2015
THE EUROPEAN
PHARMACOPOEIA:
The objectives are to harmonize
specifications for medicinal
substances, which are of general
interest to the peoples of Europe
JAMASOFT_2014-2015
interest to the peoples of Europe
and to hasten the drawing-up of
specifications for the growing
number of new medicinal
substances
appearing on the market.
THE INTERNATIONAL
THE INTERNATIONAL
PHARMACOPOEIA
PHARMACOPOEIA
(Pharmacopoea Internationalis Ph.Int)
(Pharmacopoea Internationalis Ph.Int)
• Published by the World Health Organization
(WHO).
• The International Pharmacopoeia comprises a
collection of recommended methods and
JAMASOFT_2014-2015
collection of recommended methods and
specifications that are not intended to have legal
status as such in any country, unless expressly
introduced for that purpose by appropriate
legislation, but are offered to serve as references
so that national requirements can be established on
a similar basis in any country.
THE UNITED STATES
THE UNITED STATES
PHARMACOPOEIA
PHARMACOPOEIA (USP)- THE
NATIONAL FORMULARY (NF )
is recognized as
an official compendium
of standards for drug strength, quality,
JAMASOFT_2014-2015
of standards for drug strength, quality,
purity, packaging, labeling and
storage in the U.S.A. and some other
countries.
The United States Pharmacopoeia is
recognized by FDA as the official
pharmacopoeia of the United States.
The Slovak Pharmacopoeia
The Slovak Pharmacopoeia
Pharmacopoea Slovaca
In the Slovak Republic, after four
editions of the common Czecho-Slovak
Pharmacopoeia, in the present is
JAMASOFT_2014-2015
Pharmacopoeia, in the present is
The Slovak Pharmacopoeia used.
It serves in the electronic version too.
GREECE
GREECE
Greek Pharmacopoeia
ELLINIKI PHARMACOPOIIA
Edition YEAR Language
V. Vol. 2 1998 Greek
JAMASOFT_2014-2015
V. Vol. 2 1998 Greek
1st Supplement 2000 Greek
2nd Supplement 2002 Greek
In some states with the tradition
of Homeopathy there are used
Homeopathic Pharmacopoeias.
E.g. in Germany
JAMASOFT_2014-2015
Ower there we can see
Herbal Pharmacopoeias too.
E.g. American Herbal
Pharmacopoeia
JAMASOFT_2014-2015
Some Modern Pharmacopoeias
can be used on-line,
JAMASOFT_2014-2015
or they are used in pocket-version.
Thanks
for your attention
JAMASOFT_2014-2015
for your attention

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05_Pharmacopoeias.pdf

  • 1. Pharmacopoeias (from the word φαρµακοποιία) play important role JAMASOFT_2014-2015 as the basic document basic document of the pharmaceutical legislation in all branches of drugs.
  • 2. The term Pharmacopoeia is not new. The idea of a pharmacopoeia with official status, to be followed by all, originated in Florence. The Nuovo Receptario, JAMASOFT_2014-2015
  • 3. The idea of a pharmacopoeia with official status, to be followed by all pharmacists and physicians, in all questions in all questions concerning drugs concerning drugs, JAMASOFT_2014-2015 concerning drugs concerning drugs, originated in Florence. The Nuovo Receptario, originally written in Italian, was published and became the legal standard for the city-state in 1498.
  • 4. Pharmacopoeia is a book containing directions book containing directions for the identification of samples and the JAMASOFT_2014-2015 identification of samples and the preparation of compound-medicines, and published by the authority of a government published by the authority of a government or a medical or pharmaceutical society.
  • 5. Pharmacopoeia with other words: is a book describing drugs, chemicals, and JAMASOFT_2014-2015 is a book describing drugs, chemicals, and medicinal preparations, which is issued by an officially recognized authority and serves as a standard. serves as a standard.
  • 6. The purpose of a Pharmacopoeia is to: 1. Select the best, established drugs (those "the utility of which is most fully established JAMASOFT_2014-2015 which is most fully established and best understood").
  • 7. The purpose of a Pharmacopoeia is to: 2. Set standards standards of of pharmaceutical pharmaceutical quality quality ("form from them JAMASOFT_2014-2015 quality quality ("form from them preparations and compositions in which their powers may be exerted to the greatest advantage").
  • 8. The purpose of a Pharmacopoeia is to: 3. Name them ("distinguish those articles by convenient and definite JAMASOFT_2014-2015 articles by convenient and definite names, such as may prevent trouble or uncertainty in the intercourse of physicians and pharmacists").
  • 9. The purpose of a Pharmacopoeia is to: 4. Encourage their use ("the value of a Pharmacopoeia depends upon the fidelity with which it conforms to the best state of medical knowledge of the best state of medical knowledge of the day day. Its usefulness depends upon the JAMASOFT_2014-2015 day day. Its usefulness depends upon the sanction it receives from the medical community and the public; and the extent to which it governs the language and practice of those for whose use it is intended).
  • 10. Pharmacopoeias are recognized as the most authoritative sources of information on drug standards. JAMASOFT_2014-2015 The descriptive information descriptive information about each about each drug includes drug includes: formulas, standards of purity and nomenclature, efficacy, and usually dosage, the official standards of strength, quality, purity, packaging, and labeling for drug products.
  • 11. In each pharmacopoeia there are PHARMACOPOEIAL MONOGRAPHS. JAMASOFT_2014-2015
  • 12. The pharmacopoeia The pharmacopoeia is mostly composed by some volumes. JAMASOFT_2014-2015 volumes. Each volume is updated regularly with supplements.
  • 13. Pharmacopeias Pharmacopeias at present at present 1. National (e.g. Slovak Pharmacopoeia, Greek Pharmacopoeia, ...) 2. Regional and subregional (e.g. European JAMASOFT_2014-2015 2. Regional and subregional (e.g. European Pharmacopoeia), 3. International (e.g. International Pharmacopoeia)
  • 14. Some world world- -renowned renowned pharmacopoeias pharmacopoeias: • • THE BRITISH PHARMACOPOEIA THE BRITISH PHARMACOPOEIA (B.P.) (B.P.) • • THE EUROPEAN PHARMACOPOEIA THE EUROPEAN PHARMACOPOEIA JAMASOFT_2014-2015 • • THE EUROPEAN PHARMACOPOEIA THE EUROPEAN PHARMACOPOEIA • • THE INTERNATIONAL THE INTERNATIONAL PHARMACOPOEIA PHARMACOPOEIA • • THE UNITED STATES THE UNITED STATES PHARMACOPOEIA (USP) PHARMACOPOEIA (USP)- - THE THE NATIONAL FORMULARY (NF ) NATIONAL FORMULARY (NF )
  • 15. THE BRITISH PHARMACOPOEIA (B.P.) Pharmacopoea Britannica (P.B.) has been a source of reference on the quality of substances, preparations and JAMASOFT_2014-2015 quality of substances, preparations and articles used in medicine and pharmacy for over 120 years.
  • 16. The British Pharmacopoeia 2007 JAMASOFT_2014-2015
  • 17. THE EUROPEAN PHARMACOPOEIA: The objectives are to harmonize specifications for medicinal substances, which are of general interest to the peoples of Europe JAMASOFT_2014-2015 interest to the peoples of Europe and to hasten the drawing-up of specifications for the growing number of new medicinal substances appearing on the market.
  • 18. THE INTERNATIONAL THE INTERNATIONAL PHARMACOPOEIA PHARMACOPOEIA (Pharmacopoea Internationalis Ph.Int) (Pharmacopoea Internationalis Ph.Int) • Published by the World Health Organization (WHO). • The International Pharmacopoeia comprises a collection of recommended methods and JAMASOFT_2014-2015 collection of recommended methods and specifications that are not intended to have legal status as such in any country, unless expressly introduced for that purpose by appropriate legislation, but are offered to serve as references so that national requirements can be established on a similar basis in any country.
  • 19. THE UNITED STATES THE UNITED STATES PHARMACOPOEIA PHARMACOPOEIA (USP)- THE NATIONAL FORMULARY (NF ) is recognized as an official compendium of standards for drug strength, quality, JAMASOFT_2014-2015 of standards for drug strength, quality, purity, packaging, labeling and storage in the U.S.A. and some other countries. The United States Pharmacopoeia is recognized by FDA as the official pharmacopoeia of the United States.
  • 20. The Slovak Pharmacopoeia The Slovak Pharmacopoeia Pharmacopoea Slovaca In the Slovak Republic, after four editions of the common Czecho-Slovak Pharmacopoeia, in the present is JAMASOFT_2014-2015 Pharmacopoeia, in the present is The Slovak Pharmacopoeia used. It serves in the electronic version too.
  • 21. GREECE GREECE Greek Pharmacopoeia ELLINIKI PHARMACOPOIIA Edition YEAR Language V. Vol. 2 1998 Greek JAMASOFT_2014-2015 V. Vol. 2 1998 Greek 1st Supplement 2000 Greek 2nd Supplement 2002 Greek
  • 22. In some states with the tradition of Homeopathy there are used Homeopathic Pharmacopoeias. E.g. in Germany JAMASOFT_2014-2015
  • 23. Ower there we can see Herbal Pharmacopoeias too. E.g. American Herbal Pharmacopoeia JAMASOFT_2014-2015
  • 24. Some Modern Pharmacopoeias can be used on-line, JAMASOFT_2014-2015 or they are used in pocket-version.