Transcript The 6th Edition of the European Pharmacopoeia Dr Claude Coune Head

The 6th Edition of the
European Pharmacopoeia
Dr Claude Coune
Head
Publications & Multimedia Dept
1
The European Pharmacopoeia
• New Sixth Edition
• 3 Supplements/year,
published (about) July,
September, December
• Implemented in July, January,
April
• Non-cumulative
• Change bars to indicate
changes to previous version.
General organisation: Vol. 1
Introduction
General
Notices
General
Texts
General
Monographs
Dosage
forms
Vaccines
Immunosera
Radiopharm.
Sutures
Homoeopath
y
General organisation: Vol. 2
Other specific
monographs
Index
Supplement
Published on
Implemented on
6.0
6.1
6.2
6.3
6.4 (+reagents)
6.5
6.6
6.7 (+reagents)
6.8
7.0
16/07/2007
09/2007
12/2007
07/2008
09/2008
12/2008
07/2009
09/2009
12/2009
07/2010
01/01/2008
01/04/2008
01/07/2008
01/01/2009
01/04/2009
01/07/2009
01/01/2010
01/04/2010
01/07/2010
01/01/2011
What is new in the 6th edition?
• 558 monographs redrafted in new style
– Strictly editorial = not changed technically
– Inorganic, organic and herbal monographs
only
– Will be shown as « corrected 6th edition » and
listed as such (see our Internet site)
– Monographs on the « special revision
programme » excluded.
What has changed in the 6th
Edition?.....
• Loss on drying: temperature 100-105 °C has
been replaced by 105 °C (GM: +/- 2°C) to
follow IH.
• Loss on ignition: temperature range
• atomic absorption/emission spectrometry:
precision of the limits has been increased.
…..What has changed in the 6th
Edition?.....
• Characters: ‘white’ has been replaced by ‘white or
almost white’.
• Labelling: removed statements :
–
–
–
–
the substance is free from bacterial endotoxins
free from pyrogens
sterile
name and the concentration of any added substance
(excipient, antioxidant, etc.).
• this information is already included in the general
monograph Substances for pharmaceutical use (2034).
…..What has changed in the 6th
Edition?.....
• transparency list: letters designating an
impurity followed by ‘deleted’ will no longer
be included in the monographs; it is now
permissible for the list of impurities to be
discontinuous.
…..What has changed in the 6th
Edition?.....
• Where appropriate, the CAS (Chemical Abstracts
Service) registration numbers are given for
information in the monographs.
• Retention factor Rf has been replaced by the
retardation factor RF.
• Antibiotics: upper limit of content increased to
102 per cent (if assay by liquid chromatography).
…..What has changed in the 6th
Edition?.....
• Antibiotics, Definition: (where appropriate)
substance is a ‘semi-synthetic product derived
from a fermentation product’ or a ‘fermentation
product’.
• Herbal drugs: foreign matter: usual limit of 2 per
cent m/m has been removed, as covered by
general monograph Herbal drugs (1433).
• Herbal drugs, Characters: reference to
identifications A and B (macroscopic and
microscopic descriptions) has been deleted.
…..What has changed in the 6th
Edition?.....
• Content of residual solvent is taken into account
when calculating the assay content, the specific
optical rotation and the specific absorbance (see
Substances for pharmaceutical use (2034))
without being indicated in each individual
monograph.
• Herbal drugs/Extracts, Storage: “protected from
light” specified in the general monographs
Herbal drugs (1433) and Extracts (0765). Removed
information in each individual monograph.
…..What has changed in the 6th
Edition?.....
• sintered-glass filters: reference to general
chapter 2.1.2. Comparative table of porosity
of sintered-glass filters added.
• particle or granule size indicated by a sieve
number: reference to general chapter
2.9.12. Sieve test added.
• Polymorphism: reference to general
chapter 5.9. Polymorphism added.
…..What has changed in the 6th
Edition?
• Where the heading ‘Other detectable impurities’ appears in the
Impurities section of a monograph, it is now followed by : ‘(the following
substances would, if present at a sufficient level, be detected by one or
other of the tests in the monograph. They are limited by the general
acceptance criterion for other/unspecified impurities and/or by the
general monograph Substances for pharmaceutical use (2034). It is
therefore not necessary to identify these impurities for demonstration
of compliance. See also 5.10. Control of impurities in substances for
pharmaceutical use)’.
• Many monographs have been converted to the new editorial style,
which does not entail any changes to their technical content. The list of
monographs on chemical substances and herbal drugs concerned is
available on the EDQM website:
(http://www.edqm.eu/medias/fichiers/list_of_converted_monographs.pdf)
European Pharmacopoeia
• Electronic versions
–
–
–
–
~ same price
same publication programme
cumulative
available for standalone
computers (CD)
– available online (internet)
– New license model: 1 license = 1
simultaneous user and 2
computers max.
Pharmeuropa
• Published quarterly
• Draft monographs for
comment
• News and general
information
• Reader’s tribune
Pharmeuropa Scientific Notes
• Now a separate
publication for
scientific notes
• Searchable on
scientific search
engines (PubMed in
NLM)
• Published at least
once a year
Pharmeuropa BIO
• Published 1-2x a year
• Results of collaborative
trials on the
establishment of
biological reference
substances
• Reduction of the use of
animal testing
• Searchable on scientific
search engines (PubMed
in NLM)
Standard Terms
• A glossary in 30
languages of :
– pharmaceutical
dosage forms,
– routes of
administration,
– containers
Standard Terms Online
• Address: http://www.edqm.eu/StandardTerms/
• Based on Unicode character encoding, available
only on the most recent computer operating
systems.
• Free for those having purchased the print version.
Technical guides
• Technical Guide for the Elaboration of Monographs
• Technical Guide for the Elaboration of Monographs
on Synthetic Peptides and Recombinant DNA Proteins
• Structure / Nomenclature Guide
• Free download from www.edqm.eu, download section
Combistats™
• A statistical software specifically designed
to use together with general chapter 5.3
Statistical analysis of results
• Published directly by EDQM
Checking the authenticity
• Users of the Pharmacopoeia are advised to
register their copy, using our web site:
– https://www.edqm.eu/register
• Recording the unique ID number (EPID) shown on
the label
• This registration is required for
– Users of the electronic versions (password/activation)
– Accessing our helpdesk
• Hologramme