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The 2009 British Pharmacopoeia was published for Health Ministers on the recommendation of the Medicines Commission under Section 99 (6) of Medicinal Products.
Notification
The monographs of the European Pharmacopoeia differ by the headers of the stars against the name. The term European Pharmacopoeia, used without reservation, means the sixth edition of the European Pharmacopoeia, which, unless otherwise stated, contains the main volume, published in 2007, as amended by all subsequent amendments and revisions.
Patents
Some drugs and preparations are included in this pharmacopoeia despite the existence of current or potential patent rights. Where such substances are protected by patent letters, their inclusion in this pharmacopoeia does not grant or imply a manufacturing license.
Effectiveness data
New and revised monographs of national origin were launched on 1 January 2009. The European Pharmacopoeia monographs were previously published by the Council of Europe and promoted through notices published in Belfast, Edinburgh and the London Gazettes. Introduction
The British Pharmacopoeia 2009 replaced the British Pharmacopoeia 2008. It was prepared by the British Pharmacopoeia Commission in collaboration with and with the support of its expert advisory groups and expert panels and has approximately 3,200 monographs on substances, preparations and articles used in medical practice. Some of these monographs are of national origin, others are taken from the 6th edition of the European Pharmacopoeia.
This edition, together with the accompanying edition, British Pharmacopoeia (Veterinary) 2009, includes all monographs of the 6th edition of the European Pharmacopoeia, as amended by Appendices 6.1 and 6.2. The user of the British Pharmacopoeia thus benefits from a search of its contents, a widely indexed, overview of all current UK pharmaceutical standards for medicinal products for human use. The new edition consists of the following five parts. General remark
The general notice of the British Pharmacopoeia (Part II) is amended as follows.
The designation of this General Notice is adapted to reflect the current legislative requirements described in Title V of EC Directive 2001/83 / EC, as amended.
Appendices
A list of monographs first included in the British Pharmacopoeia 2009 is given at the end of this introduction. It includes 42 new monographs of national origin and 55 new monographs copied from the 6th edition of the European Pharmacopoeia, as amended by Appendices 6.1 and 6.2.
homeopathic preparations
Four new monographs on homeopathic reserve and mother tincture supporting a simplified UK licensing body registration system have been added to this edition.
Immunological Products
This new version provides for the publication of a new monograph for Haemophilus type b
Meningococcal conjugate vaccine is group C, a vaccine widely used in immunization programs in the UK.
Unapproved drugs
With this new version, 6 separate monographs for unlicensed formulations have been added. These individual monographs are marked with a message that is not licensed in the UK. General and individual monographs are intended for all types of illicit drugs, that is, those formulations manufactured under special licenses that are manufactured illegally and under the supervision of a pharmacist. Appeals
The national monographs that have been technically modified using this edition are:
It is mentioned at the end of this introduction. For the convenience of the reader, this list shows which part of each monograph has been revised.
The list is as complete as possible. However, to ensure that the reader uses
The current standard requires reference to the full text of each monograph.
Important papers, worthy documents
Monographs of pharmaceuticals and formulated products, whose titles were changed from the names approved by the United Kingdom at the British Pharmacopoeia in 2003, previously contained the phrase "name previously used in the United Kingdom". These monographs have been amended to delete the statement in this edition.
Only the International Nonproprietary Names have been retained. The exceptions are
Adrenaline and Noradrenaline which continue to be dual-labelled in this new edition.
Adrenaline and Noradrenaline are the terms used in the European Pharmacopoeia and
therefore the official titles used in the 37 Member States party to the Convention on the
Elaboration of a European Pharmacopoeia.
Reference Substances
A number of monographs for medicinal 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. vague
The General Study of British Pharmacopoeia tablets has been revised as follows:
Remove tablet shape requirements. As a result, about 70 studies have modified the described formula.
Unlicensed drug
A joint study on unlicensed drugs
In the making, making, making
Due to the packaging and storage of non-approved oral fluids, the quality of the microorganisms meets the requirements of the Pharmacopoeia.
Infrared reference spectrum
As in the previous edition, the reference spectra are listed in alphabetical order in this edition. Seven new spectra have been added to the collection.
Appendices
A new Appendix XI B 2 (Water-soluble Extractive) has been introduced in this edition to
support the monographs for traditional herbal medicines.
The title of Appendix XIV A (Biological Assay of Antibiotics) has been harmonised with the title of the European Pharmacopoeia Method 2.7.2 (Microbiological Assay of Antibiotics). As a consequence, approximately 40 monographs have been amended in the new edition to refer to the new title.
For this edition, 14 new Appendices have been created to incorporate the methods of the
European Pharmacopoeia.
Supplementary Chapters
Changes in Monograph Titles
The Supplementary Chapter on Changes in Monograph Titles (Supplementary Chapter II A) has been amended to delete reference to the British Approved Names previously used in monograph titles in earlier editions of the British Pharmacopoeia.
Chromatograms for Information
As an additional service to users, the chromatograms and spectra, produced by the British
Pharmacopoeia Laboratory, during evaluation of a number of British Pharmacopoeia monographs for formulated preparations are collated and published in this Supplementary
Chapter (Supplementary Chapter IV I).
Editorial Changes
Chromatographic tests
The new format for chromatographic tests, introduced in the BP 2008, to delineate sample
preparation, chromatographic conditions, system suitability and acceptance criteria has been refined. The format will continue to be harmonised in future editions for all BP monographs.
Monographs for Herbal and Complementary Medicines
The monographs for herbal and complementary medicines have been reorganised into two sections in Volume III of the new edition. These sections are entitled 'Herbal Drugs and Herbal Drug Preparations' and 'Materials for use in the Manufacture of Homoeopathic Preparations' respectively. European Pharmacopoeia
All European monographs and requirements according to previous practice
The pharmacopoeia is reproduced in this edition of the British Pharmacopoeia.
Appropriate, in its companion edition, British Pharmacopoeia (Veterinary) 2009.
When the European Pharmacopoeia monograph is duplicated, this is indicated by the presence of a beaded European star next to the title. in addition,
References to European Pharmacopoeia monograph numbers are given in italics as "PhEur-Monograph xxx" just below the title. Where is the UK title
In contrast to the European Pharmacopoeia, the Pharmacopoeia has created an approved synonym (see Annex XXI B) and contains the title PhEur before the monograph number. The entire text of the European Pharmacopoeia is surrounded by two horizontal lines with the symbol "PhEur". The texts of the European Pharmacopoeia are reproduced in full, but additional explanations for use in the United Kingdom have been added at our own discretion (e.g. of course it should be noted that in case of doubt when interpreting a text of the European Pharmacopoeia on the English language version supervised by the Council of Europe published text should be referenced.
Compatibility between general methods of the European Pharmacopoeia e
The appendices of the British Pharmacopoeia are listed in each appendix with a checklist at the beginning of the appendices.
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