Pharmacopoeia
 Pharmacopoeia
 pharmacon = drug
 poieo = prepare
Substances in pharmacopoeia- called officinal drugs
Pharmacopoeias may be:
•National e.g. Brazilian, British, Chinese, Indian, Japanese,
Mexican, Spanish, United States
•Regional e.g. European (Ph.Eur.)
The 7th Edition of the European Pharmacopoeia
•International The International Pharmacopoeia
International Pharmacopoeia
A few dates…
• The history of the International Pharmacopoeia
dates back 1874…
• → 1948 First World Health Assembly established
Expert Committee on Unification of
Pharmacopoeia
• → 1950 WHA approved publication of
Pharmacopoeia Internationalis
International Pharmacopoeia
→implementation: “ready for use” by Member States
"The Ph.Int [… ] is intended to serve as source material for
reference or adaptation by any WHO Member State
wishing to establish pharmaceutical requirements. The
pharmacopoeia, or any part of it, shall have legal status,
whenever a national or regional authority expressly
introduces it into appropriate legislation."
[World Health Assembly resolution WHA3.10, WHO
Handbook of Resolutions and Decisions, Vol. 1, 1977, p.
127]
Scope since 1975
→ Model Lists of Essential Medicines
→ Medicines recommended and specifications
needed by WHO Programmes, e.g. to treat
Malaria, TB, HIV/AIDS and
→ Medicines for children!
International Pharmacopoeia
A collection of monographs and requirements for:
→ Drug substances
→ Excipients
→ Finished dosage forms
→ General methods and requirements:
dosage forms, e.g. tablets, liquid preparation for oral use
dissolution testing
→ Supplementary information, e.g. General guidelines for
Chemical Reference Substances
→ Infrared reference spectra
Specifications of substances
• Description, Chemistry, Solubility, Storage,
Labelling
• Definition, with information on polymorphism if
relevant
• Identification
• Assay
• Specific tests (sulphated ash, optical rotation,
loss on drying…)
• Related substances
Specifications of substances
• Precise description of analytical methods
• Impurities (chemical names, structures, origin)
• Any relevant information on
Performance testing (e.g. dissolution)
Stability
Validation of analytical methods
International Pharmacopoeia
current: 4th Edition + 1st Supplement
→ Consolidated in : 2 Volumes
Vol. 1: pharmaceutical substances (A-O)
Vol. 2: pharmaceutical substances (P-X)
+ dosage forms + radiopharmaceuticals
+ methods of analysis + reagents
1st Supplement - new requirements and revisions
Chemical name in
accordance with IUPAC
nomenclature rules
CAS number
International chemical
reference substance (ICRS)
Cross-reference to
a general method
Cross-reference to
the general monograph
National and regional pharmacopoeias
• Cover medicines used in the relevant country or
region
• Are legally binding "official" in the relevant
country or region
• Are prepared by a national or regional authority
PHARMACOPOEIA BOHEMICA
 3 volumes + CD, 2009
 Translation of 7th ed. of Eur. Pharmacopoieia
 Issued by The Czech Ph. Comm. Of Ministry of Health
Vol. 1 General methods and requirements
Vol. 2 Monographs A-N
 Medicines, excipients
Vol. 3
- Monographs N-Z
 Medicines, excipients
National part
- General methods and requirements
- Tables (I-XII)
 Medicines, excipients