British Pharmacopoeia 2013

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. 


 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. 


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.  

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.  

Code of Practice  

Members of the British Pharmacopoeia Commission and its supporting Expert  Advisory Groups, Panels of Experts and Working Parties are required to comply with  a Code of Practice on Declaration of Interests in the pharmaceutical industry. Details  of the Code are published on the website ( 

Chromatograms for information have been added to the Image Gallery to support new  monographs published in the British Pharmacopoeia 2013 to aid users of British  Pharmacopoeia monographs. This service will continue to increase year on year to  allow users to examine chromatograms obtained during the practical evaluation of  new monographs by the British Pharmacopoeia Commission Laboratory.  

Representative micrographs and photographs to support, and to be used in  conjunction with, the current British Pharmacopoeia monographs for Traditional  Herbal Medicines have been added. They are provided as an example of what users  might expect to see when examining powdered herbal drugs and processed herbal  drugs microscopically and macroscopically.  

International Collaboration  

Chinese Pharmacopoeia Following the signing of a Collaboration Agreement in  October 2010, the British Pharmacopoeia Commission is pleased to continue its  collaboration with the Chinese Pharmacopoeia on the development of monographs for  Traditional Chinese Herbal Medicines and mutually agreed projects.  

 World Health Organisation Following the signing of a Collaboration Agreement in  October 2011, the British Pharmacopoeia Commission is pleased to exchange  information with the International Pharmacopoeia and to collaborate on the  development of monographs for formulated preparations.  

Informal Harmonisation of Methods Following an informal harmonisation process  between two major Pharmacopoeias throughout the consultative period and, with the  co-operation of the manufacturer and simultaneous submissions of data to both the  British Pharmacopoeia and the United States Pharmacopeia, the new monographs  for Dorzolamide Eye Drops and Dorzolamide and Timolol Eye Drops have been  evaluated and published in this new edition of the British Pharmacopoeia. The British  Pharmacopoeia Commission is pleased to observe that analytical methods in these  monographs are harmonised for the two Pharmacopoeias, thus lessening the  regulatory burden for manufacturers.  



The following monographs are new additions to the British Pharmacopoeia 2013.  

Medicinal and Pharmaceutical Substances 

Aluminium Stearate* 


Candesartan Cilexetil* 


Cholesterol for Parenteral Use* 

 Anhydrous Docetaxel* 

Duloxetine Hydrochloride* 


Glucosamine Hydrochloride* 

 Glucosamine Sulfate Sodium Chloride* 

 Glycerol Formal* 


 Montelukast Sodium* 



 Nicotine Ditartrate Dihydrate* 


 Olmesartan Medoxomil* 

 Rizatriptan Benzoate* 




Water for Preparation of Extracts* 

Formulated Preparations: Specific Monographs  

Buprenorphine Injection 

Buprenorphine Transdermal Patches 

Buprenorphine Sublingual Tablets 

Cefuroxime Axetil Oral Suspension 

Cefuroxime Intracameral Injection 

Clarithromycin for Infusion 

Clonazepam Oral Suspension 

Cyclophosphamide Oral Solution 

Diphenhydramine Tablets 

Prolonged-release Dipyridamole Capsules 

Dipyridamole Infusion 

Dipyridamole Oral Suspension 

Dorzolamide Eye Drops 

Dorzolamide and Timolol Eye Drops 

Dosulepin Oral Solution 

Epirubicin Injection 

Fexofenadine Tablets 

Glycopyrronium Bromide Oral Solution 

Hydrocortisone Acetate Oral Suspension 

Lamotrigine Tablets 

Lisinopril Oral Solution 

Malathion Lotion 

Malathion Shampoo 

Mesalazine Foam Enema 

Nicorandil Tablets 

Prolonged-release Nifedipine Tablets 

Oxycodone Capsules 

Oxycodone Injection 

Oxycodone Oral Solution 

Prolonged-release Oxycodone Tablets  

Potassium Ascorbate Eye Drops 

Sodium Chloride Eye Ointment 

Prolonged-release Tamsulosin Tablets 

Triamcinolone Acetonide Nasal Spray 

Vancomycin Capsules 

 Prolonged-release Venlafaxine Tablets 

Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products 

Acanthopanax Bark*   

 Angelica Dahurica Root*   

 Angelica Pubescens Root*   

 Processed Angelica Sinensis Root*   

 Atractylodes Lancea Rhizome*   

 Atractylodes Rhizome, Largehead*   

 Berberis Aristata   

 Black Cohosh*   

 Drynaria Rhizome*   

 Eclipta Prostrata Whole Plant  

 Isatis Root*   

 Kudzuvine Root*   

 Thomson Kudzuvine Root*   

 Niaouli Oil, Cineole Type*   


 Materials for use in the Manufacture of Homoeopathic Preparations   

 Hydrastis Canadensis for Homoeopathic Preparations*   

 Impregnated Homoeopathic Pillules*   

 Pillules for Homoeopathic Preparations*   

 Immunological Products    

 Hepatitis A (Inactivated, Adsorbed) and Typhoid Polysaccharide Vaccine*   

 Radiopharmaceutical Preparations   

 Sodium Iodohippurate Dihydrate for Radiopharmaceutical Preparations*   


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