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

General organisation: Vol. 1 Introduction Dosage forms Vaccines General Notices Immunosera General Texts Radiopharm. The introduction has no legal nor regulatory value, but it is formally approved by the European Pharmacopoeia and it contains valuable information on some basic principles applicable to the use of the European Pharmacopoeia. The general notices consitute an official part of the European Pharmacopoeia. This chapter contains a number of definitions, instructions on how to apply and to understand the requirements of the specific monographs. General texts, all listed in Chapter 5, are not normally legally binding (except for chapter 5.10 which will be discussed more in depth later on today). They provide additional information intended to help the user of the Pharmacopoeia in certain areas such as statistical evaluation of results of biological assays, determination of solubility, hygroscopicity, … General monographs are a very important section of the European Pharmacopoeia, which greatly influence the way specific monographs are to be applied and interpreted. Each specific monograph refers back to at least one, often several, general monograph. We will see, in a few case studies, how this mechanism functions. Dosage forms: the European Pharmacopoeia does not include monographs on finished formulated preparations but only general texts of pharmaceutical dosage forms. They are mandatory for any dosage form marketed in Europe. Sutures General Monographs Homoeopathy

General organisation: Vol. 2 Other specific monographs Index “Other specific monographs” includes inorganic and organic substances as well as herbals, herbal extracts and essential oils.

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? 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