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The 6th Edition of the

European Pharmacopoeia

The 6th Edition of the

European Pharmacopoeia

Dr Claude CouneHead

Publications & Multimedia Dept

Dr Claude CouneHead

Publications & Multimedia Dept

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.

IntroductIntroductionionIntroductIntroductionion

GeneralGeneralNoticesNoticesGeneralGeneralNoticesNotices

GeneralGeneralTextsTextsGeneralGeneralTextsTexts

GeneralGeneralMonographMonographss

GeneralGeneralMonographMonographss

General organisation: Vol. 1General organisation: Vol. 1

Dosage Dosage formsforms

Dosage Dosage formsforms

VaccinesVaccinesVaccinesVaccines

ImmunoserImmunoseraa

ImmunoserImmunoseraa

RadiopharRadiopharm.m.

RadiopharRadiopharm.m.

SuturesSuturesSuturesSutures

HomoeopatHomoeopathyhy

HomoeopatHomoeopathyhy

General organisation: Vol. 2General organisation: Vol. 2

Other specificOther specificmonographsmonographs

Other specificOther specificmonographsmonographs

IndexIndexIndexIndex

Supplement Published on Implemented on

6.0 16/07/2007 01/01/2008

6.1 09/2007 01/04/2008

6.2 12/2007 01/07/2008

6.3 07/2008 01/01/2009

6.4 (+reagents) 09/2008 01/04/2009

6.5 12/2008 01/07/2009

6.6 07/2009 01/01/2010

6.7 (+reagents) 09/2009 01/04/2010

6.8 12/2009 01/07/2010

7.0 07/2010 01/01/2011

What is new in the 6th edition?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.

• 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changed in the 6th Edition?.....What has changed in the 6th Edition?.....• Loss on drying: temperature 100-105 °C has been replaced by 105 °C (GM: +/- 2°C) to follow IH.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.

• 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?.....…..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).

• 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?.....…..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.

• 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?.....…..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).

• 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?.....…..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.

• 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?.....…..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.

• 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?.....…..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.

• 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?…..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)

• 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.

PharmeuropaPharmeuropa

• Published quarterly

• Draft monographs for comment

• News and general information

• Reader’s tribune

• Published quarterly

• Draft monographs for comment

• News and general information

• Reader’s tribune

Pharmeuropa Scientific NotesPharmeuropa Scientific Notes• Now a separate publication for scientific notes

• Searchable on scientific search engines (PubMed in NLM)

• Published at least once a year

• Now a separate publication for scientific notes

• Searchable on scientific search engines (PubMed in NLM)

• Published at least once a year

Pharmeuropa BIOPharmeuropa 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)

• 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 TermsStandard Terms•A glossary in 30 languages of : –pharmaceutical dosage forms,

–routes of administration,

–containers

•A glossary in 30 languages of : –pharmaceutical dosage forms,

–routes of administration,

–containers

Standard Terms OnlineStandard Terms Online

• Address: http://www.edqm.eu/StandardTerms/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.

• Address: http://www.edqm.eu/StandardTerms/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 guidesTechnical 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

• 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™Combistats™

• A statistical software specifically designed to use together with general chapter 5.3 Statistical analysis of results

• Published directly by EDQM

• A statistical software specifically designed to use together with general chapter 5.3 Statistical analysis of results

• Published directly by EDQM

Checking the authenticityChecking the authenticity• Users of the Pharmacopoeia are advised to register their copy, using our web site:– https://www.edqm.eu/registerhttps://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

• Users of the Pharmacopoeia are advised to register their copy, using our web site:– https://www.edqm.eu/registerhttps://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