6th Edition Book & CD-ROM
The EDQM is now taking orders online for the 6th Edition of the European Pharmacopoeia (book, CD-ROM and Internet versions). The electronic version of the 6th Edition European Pharmacopoeia will be available on CD-ROM and Internet only. The Intranet version of the European Pharmacopoeia is not available anymore.
CD-ROM: The CD-ROM version is intended for installation onto an individual computer and a separate CD-ROM will be sent for each licence purchased.
Editorial revision of monographs
(conversion into a new editorial style)
During the course of the 3rd Edition, a new, improved editorial style was adopted, particularly for monographs on organic chemicals. New and extensively revised monographs were generally published in the new style for the 4th and 5th Editions. For the 6th Edition, a large number of monographs published in the old style for the 5th Edition have been converted to the new style so that there is greater uniformity in editorial presentation. Conversion to the new style does not affect the technical content of the monographs. Since the editorial revision does not affect the technical content, the changes are not tracked by the use of lines in the margin.
ÍNDICE
IV. CONTENTS OF THE 6th EDITION
The 6th Edition consists of all texts published in the 5th Edition, which may subsequently have been revised or corrected, and new texts.
For the information of the reader, lists are given below of monographs and general chapters that are new, or that have been revised, corrected or deleted, and texts whose title has been changed for the 6th Edition.
The version date (01/2008 for volume 6.0) and the reference number (4 digits for monographs and 5 digits for general chapters) are specified above the title of each text
(monographs and general chapters). The version date makes it possible to identify the successive versions of revised texts in different volumes of the 6th Edition. Corrections that are indicated by the note ‘corrected 6.0’ under the version date are to be taken into account from the publication date of the volume.
For the 6th Edition, the following systematic modifications have been made to the texts of the European Pharmacopoeia.
— Inthetest for lossondrying(2.2.32) in the monographs, the temperature range of 100-105 °C has been replaced by 105 °C alone (as the general method states that drying
is carried out at the prescribed temperature ± 2 °C), to follow the approach adopted by the Pharmacopoeial
Discussion Group for pharmacopoeial harmonisation.
— In the test for loss on ignition in the monographs, a temperature range has been introduced.
— In tests using atomic absorption spectrometry and atomic emission spectrometry, the precision of the limits has been increased.
— In the Characters section, ‘white’ has been replaced by ‘white or almost white’.
— In the Labelling section, it will no longer be mentioned that, where appropriate, the label includes statements that the substance is free from bacterial endotoxins,
free from pyrogens and sterile since this information is already included in the general monograph Substances for pharmaceutical use (2034). This also applies to the
indication of the name and the concentration of any added substance (excipient, antioxidant, etc.).
— In the 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.
— Where appropriate, the Chemical Abstracts Service (CAS) registration numbers are given for information in the monographs.
— The retention factor Rf has been replaced by the retardation factor RF.
— In monographs on antibiotics, the upper limit of content has been increased to 102 per cent when an assay is carried out using liquid chromatography.
— In monographs on antibiotics, where appropriate, the definition mentions that the substance is a ‘semi-synthetic product derived from a fermentation product’ or a
‘fermentation product’.
— In monographs on herbal drugs, the usual limit of 2 per cent m/m for foreign matter has been moved from general method 2.8.2. Foreign matter to the general monograph
Herbal drugs (1433); this information has therefore been deleted from the specific monographs for drugs covered by this general monograph.
— In monographs on herbal drugs, the reference to identifications A and B (macroscopic and microscopic descriptions) has been deleted from the Characters section.
— In accordance with the general monograph Substances for pharmaceutical use (2034), the content of residual solvent is taken into account for calculation of the assay
content of the substance, the specific optical rotation and the specific absorbance. This information is therefore no longer indicated in the specific monographs concerned.
— The general monographs Herbal drugs (1433) and Extracts (0765) specify storage protected from light ; this information has therefore been deleted from the specific
monographs on substances and preparations covered by these general monographs.
— A reference to general chapter 2.1.2. Comparative table of porosity of sintered-glass filters has been added whenever reference is made to ‘sintered-glass filters’.
— A reference to general chapter 2.9.12. Sieve test has been added whenever particle or granule size is indicated by a sieve number.
— A reference to general chapter 5.9. Polymorphism has been added to monographs in which polymorphism is mentioned.
— Where the heading ‘Other detectable impurities’ appearsin 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.
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