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The British Pharmacopoeia 2012 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 2012 replaces the 2012 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) 2012, 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 2012 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) 2012
Effective Date
The effective date for British
Pharmacopoeia monographs in this edition is 1 January 2012. 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 2012 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 2012. 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 2012.
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 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 2012-18 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 2012. 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) 2012.
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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