The British Pharmacopoeia 2013 is published for the Health Ministers on the recommendation of the Commission on Human Medicines in accordance with section 99(6) of the Medicines Act 1968.
The Commission on Human Medicines believes that the British Pharmacopoeia contributes significantly to the overall control of the quality of medicinal products by providing an authoritative statement of the quality that a product, material or article is expected to meet at any time during its period of use. The Pharmacopoeial standards, which are publicly available and legally enforceable, are designed to complement and assist the licensing and inspection processes and are part of the system for safeguarding purchasers and users of medicinal products.
The Commission on Human Medicines wishes to record its appreciation of the services of all those who have contributed to this important work.
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The British Pharmacopoeia
2013 supersedes the British Pharmacopoeia 2012. It has been prepared by the British Pharmacopoeia
Commission, with the collaboration and
support of its Expert Advisory Groups, Panels of Experts and Working
Parties and contains almost 3400
monographs for substances, preparations and articles used in the practice of medicine. Some of these
monographs are of national origin, while
others have been reproduced from the 7th Edition of the European
Pharmacopoeia. This edition, together
with its companion edition, the British Pharmacopoeia (Veterinary) 2013, incorporates all the
monographs of the 7th Edition of the European
Pharmacopoeia, as amended by Supplements 7.1 to 7.5. The user of the
British Pharmacopoeia thereby benefits by
finding within this comprehensively indexed
compendium all current United Kingdom pharmacopoeial standards for
medicines for human use.
The BP 2013 comprises six
volumes as follows.
Volumes I and II
Medicinal Substances
Volume III
Formulated Preparations:
General Monographs Formulated Preparations: Specific Monographs
Volume IV
Herbal Drugs, Herbal Drug
Preparations and Herbal Medicinal Products Materials for use in the Manufacture
of Homoeopathic Preparations Blood-related Products Immunological Products
Radiopharmaceutical Preparations Surgical Materials
Volume V
Infrared Reference Spectra
Appendices Supplementary Chapters Index
Volume VI
British Pharmacopoeia
(Veterinary) 2013
Effective Date
The effective date for
British Pharmacopoeia monographs in this edition is 1 January 2013.
National monographs omitted
from this or earlier editions of the British
Pharmacopoeia remain effective in accordance with Section 65(4) of the
Medicines Act 1968.
Implementation dates
regarding European Pharmacopoeia publications are provided in Supplementary Chapter IV B: Dates of
Implementation. European Pharmacopoeia
monographs are identified by a chaplet of stars alongside the title.
General Notices
Part II
The British Pharmacopoeia
General Notices (Part II) have been amended as follows.
Crude Drugs; Traditional
Herbal and Complementary Medicines
Monograph Title This General
Notice has been amended to delete references to
the acronyms THM and THMP.
Unlicensed Medicines
This General Notice has been
editorially amended to harmonise the reference to Manufacturer's 'Specials' Licence throughout
the Pharmacopoeia.
Part III
The British Pharmacopoeia
General Notices (Part III) have been amended to
harmonise with the changes published in Supplement 7.5 of the 7th
edition of the European Pharmacopoeia.
Additions
A list of monographs
included for the first time in the British Pharmacopoeia 2013 is given at the end of this introduction. It
includes 41 new monographs of national origin
and 40 new monographs reproduced from the 7th Edition of the
European Pharmacopoeia as amended by
Supplements 7.1 to 7.5.
Traditional Herbal
Medicines; Homoeopathic Preparations
Work is continuing on the
development of monographs for materials and processed materials used in Traditional Herbal
Medicines with the addition of 2 new
monographs in this edition. The requirements for the quality of the
material are provided in the monograph
to set the standards for Traditional Herbal Medicines in the UK and to assist the registration scheme
by the UK Licensing Authority. The
British Pharmacopoeia Commission, however, has not assessed the safety
and efficacy of the material in
traditional use.
Likewise, the British
Pharmacopoeia Commission has not assessed the safety and efficacy of materials for use in homoeopathic
preparations for which monographs are
published.
Unlicensed Medicines
With this new edition, a
further 9 monographs for unlicensed formulations have been added. These individual monographs are
characterised by a statement that they are
not currently licensed in the United Kingdom. The general and individual
monographs are intended to apply to all
types of Unlicensed Medicines, that is, those
formulations prepared under a Manufacturer's 'Specials' Licence and
those prepared extemporaneously under
the supervision of a pharmacist.
Revisions
A significant number (619)
of national monographs have been amended by means of this edition. Of these monographs, those with
major technical revisions are listed at
the end of this Introduction. For the benefit of the reader this list
indicates the section, or sections, of
each monograph which has/have been revised.
The list of revisions
appended to this Introduction is as comprehensive as practicable. However, to ensure that the
reader uses the current standard, it is
essential to refer to the full text of each individual monograph.
Title Changes
Parenteral Preparations
Following a review by the British Pharmacopoeia
Commission's Expert Advisory Group on Pharmacy, the term
"Intravenous" has been removed
from the title of 35 monographs for Intravenous Infusions in the BP 2013.
In addition, the Definition statements
have been revised for consistency and to ensure
that they reflect currently marketed products.
Herbal Drugs, Herbal Drug
Preparations and Herbal Medicinal Products The
titles of 15 monographs for Traditional Herbal Medicines have been
amended to delete reference to 'THM' and
'THMP' extensions in the BP 2013.
Labelling Requirements
A phased revision of
Labelling requirements in the British Pharmacopoeia was initiated with the publication of a revised
General Notice for Labelling in the British
Pharmacopoeia 2009 and revision of the Labelling statements in the
General Monographs in the British
Pharmacopoeia 2012.
Following a review by the
British Pharmacopoeia Commission's Expert Advisory Group on Pharmacy and, in collaboration with
the MHRA Licensing Authority, all
statements required by the European Directive 2001/83/EC have been
omitted from the specific monographs in
this edition of the British Pharmacopoeia to avoid duplication.
Reference Substances
21 monographs for medicinal
and pharmaceutical substances and formulated
preparations of the BP have been amended to refer to new British
Pharmacopoeia Chemical Reference
Substances established by the British Pharmacopoeia Laboratory.
Omissions
18 monographs have been
omitted from the British Pharmacopoeia 2013. The list of omissions is appended at the end of this
Introduction.
Infrared Reference Spectra
As with the previous
edition, the reference spectra are placed in alphabetical order within this edition. Six new spectra have
been added to the collection. The spectrum
for Sertraline Hydrochloride has been revised in this edition.
Appendices
Three new Appendices to
harmonise with the European Pharmacopoeia were first published in the British Pharmacopoeia 2012
electronic updates. These have been
consolidated in the new edition as follows:
Appendix VIII T: Methyl,
Ethyl and Isopropyl Methanesulfonate in Active Substances (Ph Eur method 2.5.38);
Appendix VIII V:
Methanesulfonyl Chloride in Methanesulfonic Acid (Ph Eur method 2.5.39);
Appendix XII C8: Preparations
for Nebulisation: Characterisation (Ph Eur method 2.9.44).
Editorial Changes
Chromatographic Tests
The format for
chromatographic tests to delineate sample preparation, chromatographic conditions, system
suitability and acceptance criteria has been
applied to a further 37 monographs. The format will continue to be
harmonised in future editions for all
British Pharmacopoeia monographs.
European Pharmacopoeia
In accordance with previous
practice, all monographs and requirements of the European Pharmacopoeia are reproduced in this
edition of the British Pharmacopoeia or,
where appropriate, within its companion edition, the British Pharmacopoeia (Veterinary) 2013.
Where a monograph has been reproduced from the
European Pharmacopoeia, this is
signified by the presence of a European chaplet of stars alongside its
title. Additionally, reference to the
European Pharmacopoeia monograph number is
included immediately below the title in italics in the form 'Ph Eur
monograph xxxx'. Where the title in the
British Pharmacopoeia is different from that in the European Pharmacopoeia, an approved synonym has been
created (see Appendix XXI B) and the
European Pharmacopoeia title is included before the monograph number. The entire European Pharmacopoeia text is
delineated by two horizontal lines bearing the
symbol 'Ph Eur'.
The European Pharmacopoeia texts have been
reproduced in their entirety but, where
deemed appropriate, additional statements of relevance to UK usage have been added (e.g. action and use statement, a
list of British Pharmacopoeia
preparations). It should be noted, however, that in the event of doubt
of interpretation in any text of the
European Pharmacopoeia, the text published in English under the direction of the Council of Europe should be
consulted.
Correspondence between the general methods of
the European Pharmacopoeia and the
appendices of the British Pharmacopoeia is indicated in each appendix and
by inclusion of a check list at the
beginning of the appendices section.
Pharmacopoeial Requirements
It should be noted that any
article intended for medicinal use which is described by a name at the head of a monograph in the
current edition of the Pharmacopoeia must
comply with that monograph 'whether or not it is referred to as
BP'.
It is also important to note
that no requirement of the Pharmacopoeia can be taken in isolation. A valid interpretation of any
particular requirement depends upon it being
read in the context of (i) the monograph as a whole, (ii) the specified
method of analysis, (iii) the relevant
General Notices and (iv) where appropriate, the relevant general monograph(s). Familiarity with the
General Notices of the Pharmacopoeia
will facilitate the correct application of the requirements. Additional
guidance and information on the basis of
pharmacopoeial requirements is provided in
Supplementary Chapter I. This non-mandatory text describes the general
underlying philosophy and current
approaches to particular aspects of pharmacopoeial control.
The British Pharmacopoeia Commission is appointed, on behalf of the Secretary of State for Health, by the Appointments Commission, the body responsible for appointments to all of the Medicines Act 1968 Advisory Bodies.
The duties of the British Pharmacopoeia Commission are as follows:
(a) the preparation under section 99(1) of the Act of any new edition of the British Pharmacopoeia;
(b) the preparation under section 99(1) of the Act, as given effect by section 102(1) thereof, of any amendments of the edition of the British Pharmacopoeia published in 1968 or any new edition of it;
(c) the preparation under section 100 of the Act (which provides for the preparation and publication of lists of names to be used as headings to monographs in the British Pharmacopoeia) of any list of names and the preparation under that section as given effect by section 102(3) of the Act of any amendments of any published list;
There are 1 to 5 Volume in BP 2013
