British Pharmacopoeia in software form

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

British Pharmacopoeia in software form


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British Pharmacopoeia in software form




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