The 10th Edition consists of new texts as well as all current texts from the 9th Edition, some of which have been revised or corrected.
Lists of the monographs and general chapters that, for the 10th Edition, are new, revised or corrected, or have had their titles or chapter numbers changed, are given below.
The version date (for example 01/2020 for a text that is new or revised for the 10th Edition), completed by ‘corrected X.X’ if a corrected version of the text has subsequently been published in Supplement X.X, and the reference number (4 digits for monographs and 5 digits for general chapters) are specified above the title of each monograph and general chapter.
The version date, completed by ‘corrected X.X’ if appropriate, makes it possible to identify the successive versions of texts in different editions.
The volume in which the current version was first published is stated in the Knowledge database on the EDQM website.
As of the 10th Edition, all revised or corrected parts of a text are indicated by vertical lines in the margin and horizontal lines in the margin indicate where parts of a text have been deleted. Lines in the margin that were present in revised or corrected texts in the previous edition are deleted with each new edition.
Corrected texts are to be taken into account as soon as possible and not later than the end of the month following the month of publication of the volume. New and revised texts are to be taken into account not later than the implementation date.
A barcode is included at the start of each text, providing a link to further information on the text (e.g. the Knowledge database) for smartphones and tablets with a camera and a barcode reader app.
In addition to corrections made to individual texts, the following decisions and systematic modifications have been made to the texts of the European Pharmacopoeia for the 10th Edition.
– For texts not currently undergoing revision, the wording used in the calculation of percentage contents in the quantitative expression of acceptance criteria in tests for related substances has been modified to specify the full name of the substance (i.e. including counter-ions, hydrates etc.).
– Tests using diphosphorus pentoxide, predominantly tests for loss on drying, have been modified, where possible, to avoid the use of this substance due to its toxicity.
– The names and descriptions of the reagents used to describe stationary phases for gas chromatography have been revised.
– ‘Tamper-proof ’ has been replaced by ‘tamper-evident’.
– Reference to general chapter 2.8.23. Microscopic examination of herbal drugs has been added when microscopic examination is carried out using a powder with a non-standard sieve size.
– The terms ‘coarse’ and ‘coarsely’ have been deleted from ‘coarse powder (1400) (2.9.12)’ and ‘coarsely powdered herbal drug (1400) (2.9.12)’.
– Results are expressed in per cent instead of per cent m/m in the tests Dry residue of extracts (2.8.16) and Loss on drying of extracts (2.8.17).
Individual copies of texts published in this edition will not be supplied.
Subscribers to the current version (book or electronic) of the European Pharmacopoeia have access to an online archive version of all obsolete editions and supplements of the European Pharmacopoeia in PDF format.
A list of new reagents published during the course of this edition is available under ‘Useful information’ in Pharmeuropa Online. |
