In this post, you can download British Pharmacopoeia 2013 in pdf format for free. There are 4 Volumes available of British Pharmacopoeia 2013.
The British Pharmacopoeia 2013 was issued to the Minister of Health in accordance with Article 99 (6) of the Pharmaceutical Affairs Law of 1968, based on the recommendations of the Human Drugs Commission.
The Human Pharmacopoeia believes that the British Pharmacopoeia
will contribute significantly to the overall quality control of medicines by
formalizing the quality of a product, substance, or substance that must be met
at any time during use. .. Publicly available and legally enforceable
pharmacopoeial standards are designed to supplement and support the licensing
and testing process and form part of the drug purchaser and user protection
system.
The Committee for Medicinal Products for Human Use wants to record
its appreciation for the services provided by all who have contributed to this
important task.
British Pharmacopoeia 2013 replaces the 2013 British
Pharmacopoeia. 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 studies that have been omitted from
the British Pharmacopoeia or earlier versions are in effect under Section 65(4)
of the Medicines Act 1968.
Effective dates for the European Pharmacopoeia publications are
listed in Appendix IV B: Effective dates. European Pharmacopoeia studies can be
identified by a star crown next to their title.
General Notice
Part 2
The UK Pharmacopoeia Public Notice (Part 2) has been revised as
follows.
Herbal medicine; Traditional Chinese Medicine and Complementary
Medicine
Message Title This public notice has been modified to remove
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 3
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. However, the British
Pharmacopoeia Commission has not assessed the safety and efficacy of the
material under traditional use.
Similarly, the British Pharmacopoeia Commission has not assessed
the safety and efficacy of the materials for use in homeopathic preparations
for which monographs have been published.
Unapproved drugs
With this new edition, 9 more monographs have been added for
unapproved formulations. These individual monographs are identified by the
statement that they are not currently authorized in the UK. General and
individual monographs apply to all types of unauthorized drugs, e.g. H. those
formulations produced under the license of the manufacturer
"Specials" and those produced extemporaneously under the supervision
of a pharmacist. amendment
A significant number (619) of national monographs have been
modified by this edition. Among these monographs, those with major technical
revisions are listed at the end of this introduction. For the convenience of
the reader, this list identifies the section of each monograph that has been
modified.
The revision list that accompanies this introduction is as
extensive as is practical. However, it is essential for the reader to refer to
the full text of each monograph in order to use the current standard.
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 2013.
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 substance
Twenty-one monographs and formulated formulations of
pharmaceuticals and pharmaceuticals from BP have been amended to refer to the
new British Pharmacopoeia chemical references established by the British
Pharmacopoeia.
The 2013-18 British Pharmacopoeia monographs have been omitted.
The abbreviated list is added to the end of this beginning.
Infrared reference spectrum
As in the previous edition, also in this edition the reference
spectra are arranged in alphabetical order. Six new spectra have been added to
the collection. The spectrum of sertraline hydrochloride has been modified in
this edition.
Attachment
Three new annexes, harmonized with the European Pharmacopoeia,
have been published for the first time in an electronic update of the British
Pharmacopoeia 2013. These have been incorporated into the new edition as
follows:
Annex VIII T: methyl, ethyl and isopropyl methanesulfonates of the
active substances (method Ph Eur 2.5.38);
Annex VIII V: methanesulfonyl chloride in methanesulfonic acid
(method Ph Eur 2.5.39);
Appendix XII C8: Preparation of spraying: Characterization (Method
Ph Eur 2.9.44).
Chromatography Test
A chromatographic test format to describe sample preparation,
chromatographic conditions, system suitability, and acceptance criteria was
applied to 37 additional monographs. The format will be more harmonized for all
British Pharmacopoeia monographs in future editions. European Pharmacopoeia
In accordance with past practice, all monographs and requirements
of the European Pharmacopoeia are reproduced in this Pharmacopoeia or, if
applicable, the accompanying edition The Pharmacopoeia (Veterinary) 2013.
If the monograph is taken from the European Pharmacopoeia, it indicates that there is a European star halo next to the title. Reference is also made to the monograph number of the European Pharmacopoeia, printed in italics in the form "Ph Eur monograph xxxx", immediately below the title. Where the title of the UK Pharmacopoeia differs from that of the European Pharmacopoeia, an approved synonym has been generated (see Annex XXI B) and the title of the European Pharmacopoeia is inserted before the monograph number. The entire text of the European Pharmacopoeia is separated by two horizontal lines with the symbol "Ph Eur". The texts of the European Pharmacopoeia are reproduced in their entirety, but additional explanations related to their use in the UK have been added where appropriate.
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