Acacia

Acacia
(Ph Eur monograph 0307)
Ph Eur
Definition
Acacia is the air-hardened, gummy exudate flowing naturally from or obtained by incision of the trunk and branches of Acacia senegal L. Willdenow and other species of Acacia of African origin.
Characters
Acacia is almost completely but very slowly soluble, after about 2 h, in twice its mass of water leaving only a very small residue of vegetable particles; the liquid obtained is colourless or yellowish, dense, viscous, adhesive, translucent and weakly acid to blue litmus paper. Acacia is practically insoluble in alcohol.
It has the macroscopic and microscopic characters described under identification tests A and B.
Identification
A. Acacia occurs as yellowish-white, yellow or pale amber, sometimes with a pinkish tint, friable, opaque, spheroidal, oval or reniform pieces (tears) of a diameter from about 1 cm to 3 cm, frequently with a cracked surface, easily broken into irregular, whitish or slightly yellowish angular fragments with conchoidal fracture and a glassy and transparent appearance. In the centre of an unbroken tear there is sometimes a small cavity.
B. Reduce to a powder (355). The powder is white or yellowish-white. Examine under a microscope using glycerolR (50 per cent V/V). The powder presents angular, irregular, colourless, transparent fragments. Only traces of starch or vegetable tissues are visible. No stratified membrane is apparent.
C. To 2 ml of solution S (see Tests) add 8 ml of waterR; the solution is laevorotatory.
D. Examine the chromatograms obtained in the test for glucose and fructose. The chromatogram obtained with the test solution shows three zones due to galactose, arabinose and rhamnose. No other important zones are visible, particularly in the upper part of the chromatogram.
E. Dissolve 1 g of the powdered drug (355) in 2 ml of waterR by stirring frequently for 2 h. Add 2 ml of alcoholR. After shaking, a white, gelatinous mucilage is formed which becomes fluid on adding 10 ml of waterR.
Tests
Solution S
Dissolve 3.0 g of the powdered drug (355) in 25 ml of waterR by stirring for 30 min. Allow to stand for 30 min and dilute to 30 ml with waterR.

Radiopharmaceutical Preparations

Radiopharmaceutical Preparations
Dried Iodinated [125I] Fibrinogen1
Sodium Iodide [125I] Solution1
1Monograph suppressed by European Pharmacopoeia Commission on 1 January 2003.
2Monograph transferred to the British Pharmacopoeia (Veterinary).
3Monograph suppressed by European Pharmacopoeia Commission on 1 July 2003
Technical Changes
The following monographs in the BP 2003 have been technically amended since the publication of the BP 2002. This list does not include revised monographs of the European Pharmacopoeia. An indication of the nature of the change or the section of the monograph that has been changed is given in italic type in the right hand column.
Medicinal and Pharmaceutical Substances
ormulated Preparations: Specific Monographs
4Monograph transferred from Volume I (Medicinal Substances) to Volume III (Formulated Preparations).
Changes in Title
The following lists give the alterations in the titles of monographs of the British Pharmacopoeia 2002 that have been retained in the British Pharmacopoeia 2003.
The changes listed below have arisen following changes in titles of monographs of the European Pharmacopoeia.
The changes listed below have arisen following the change from dual-labelled titles to titles including only the recommended International Nonproprietary Names (see above). Consequential changes to the Labelling and Preparation(s) statements have also been made to these monographs, where appropriate.

Medicinal and Pharmaceutical Substances

Medicinal and Pharmaceutical Substances
Calcium Sodium Lactate
Capreomycin Sulphate
Cocillana
Corticotropin1
Hydroxyprogesterone Caproate
Isoaminile
Oxyphenbutazone1
Sulfadimidine2
Sulfadimidine Sodium
Formulated Preparations: General Monographs
Tinctures1
Formulated Preparations: Specific Monographs
Capreomycin Injection
Cloxacillin Capsules
Cloxacillin Injection
Cloxacillin Oral Solution
Docusate Tablets
Hydroxyprogesterone Injection
Lypressin Injection3
Macrogol Ointment
Oxyphenbutazone Eye Ointment
Sodium Citrate Tablets
Sorbitol Intravenous Infusion

General Monographs

General Monographs
The General Monographs for dosage forms are grouped together at the beginning of Volume III. They are followed by the monographs for the individual formulated preparations arranged in alphabetical order. The General Monographs of the European Pharmacopoeia apply to all individual dosage forms of the type defined rather than only to those preparations for which a specific monograph is included (see the General Notices).
Infrared Reference Spectra
To enable the user to locate a particular reference spectrum without difficulty, all have been assigned specific serial numbers within this edition. These are then cited within the text wherever reference to that spectrum is made.
Three new spectra have been added sequentially to the previous collection. A number of spectra that are no longer required have been removed from this edition.
Acknowledgements
The British Pharmacopoeia Commission is greatly indebted to the members of its advisory Committees and Consultative Groups without whose dedicated enthusiasm and assistance this edition could not have been prepared.
Close co-operation has continued with many organisations at home and overseas. These include the Medicines and Healthcare products Regulatory Agency (of which the Pharmacopoeia secretariat and laboratory staff are a part), the National Institute for Biological Standards and Control, the Veterinary Medicines Directorate, the Royal Pharmaceutical Society of Great Britain, the Association of the British Pharmaceutical Industry, the European Pharmacopoeia Commission and the European Directorate for the Quality of Medicines, the Therapeutic Goods Administration (Australia), the Health Protection Branch of the Canadian Department of Health and Welfare, the Committee of Revision of the United States Pharmacopeia, the Essential Drugs and Other Medicines Department of the World Health Organization (WHO) and the WHO Collaborating Centre for Chemical Reference Substances.
The British Pharmacopoeia Commission also acknowledges the advice of the publisher and the contribution made by Mr P Shaw, The Stationery Office, in the production of this edition which was published using the innovative ActiveTextTM software.

Storage

Storage
The General Notice on Storage included in Part II of the General Notices has been amended to specify that, unless otherwise stated in the monograph, the substances and preparations described in the British Pharmacopoeia are kept in well-closed containers and stored at a temperature not exceeding 25°. The monographs for medicinal substances and formulated preparations have therefore been amended to reflect the change in the General Notice.
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).
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 xxx'. 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 a cross-reference to the Ph Eur title has been included in the Index. The entire European Pharmacopoeia text is then bounded by two horizontal lines bearing the symbol ¢Ph Eur¢.
The European Pharmacopoeia texts have been reproduced in their entirety without editorial modification but, where deemed appropriate, additional statements of relevance to UK usage have been added (e.g. action and use statement, a list of BP 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 2003 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. 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.

Introduction

Introduction
This edition of the British Pharmacopoeia supersedes the British Pharmacopoeia 2002. It has been prepared by the British Pharmacopoeia Commission with the collaboration and support of its advisory Committees and experts, and contains nearly 2900 monographs for substances and articles used in the practice of medicine. Some of these monographs are of national origin while others have been reproduced from the 4th edition of the European Pharmacopoeia. This new edition, together with its companion edition, the British Pharmacopoeia (Veterinary) 2003, contains all monographs of the 4th edition of the European Pharmacopoeia as amended by Supplements 4.1, 4.2, 4.3, 4.4 and 4.5. The user of the British Pharmacopoeia thereby benefits by finding within this one, comprehensively indexed, compendium all current United Kingdom pharmacopoeial standards for medicines for human use. The new edition comprises six volumes as follows:-
Effective Date
The effective date for this edition is 1st December 2003 unless otherwise stated.
Where a monograph which appeared previously in an earlier edition of the British Pharmacopoeia has not been included in this new edition, it remains effective in accordance with Section 65(4) of the Medicines Act 1968.
Additions
A list of monographs included within the Pharmacopoeia for the first time is given at the end of this introduction. It includes 12 new monographs of national origin and 68 new monographs reproduced from Supplements 4.3, 4.4 and 4.5 of the European Pharmacopoeia.
Revisions
National monographs which have been amended technically by means of this edition are also 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 is as comprehensive as possible. 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
Monographs for medicinal substances and formulated preparations that were dual-labelled with both the recommended International Nonproprietary Name and the British Approved Name in the British Pharmacopoeia 2002 have been amended in this edition so that only the recommended International Nonproprietary Names are used. This is in accordance with the implementation of Directive 92/27/EEC. The two exceptions to the changes are Adrenaline and Noradrenaline for which the British Approved Names are retained. These are the names used in European Pharmacopoeia monographs and their associated formulation monographs. The changes are explained fully in Supplementary Chapter II A and the list of title changes is also included at the end of the Introduction. The list of Approved Synonyms has also been amended to reflect the changes. The former names used in the United Kingdom are included in a statement at the beginning of the relevant monograph for information.
The statement 'When [former title] is prescribed or demanded, [current title] shall be dispensed or supplied', previously included in monographs to provide continuity, has been deleted from monographs in this edition.
All those involved in the provision of medicines to the public are being alerted to the changes through an extensive communication strategy developed by the Medicines and Healthcare products Regulatory Agency and the Department of Health.

Formulated Preparations: Specific Monographs

Formulated Preparations: Specific Monographs
Cefradine Oral Suspension
Dexamethasone Sodium Phosphate Injection
Estradiol Transdermal Patches
Lacidipine Tablets
Levonorgestrel Tablets
Metronidazole Oral Suspension
Norgestrel Tablets
Potassium Dihydrogen Phosphate Concentrate, Sterile
Quinine Dihydrochloride Intravenous Infusion
Simeticone Suspension for Infants
Trimethoprim Oral Suspension
Immunological Products
Diphtheria, Tetanus and Hepatitis B (rDNA) Vaccine (Adsorbed)*
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Vaccine (Adsorbed)*
Diphtheria, Tetanus, Pertussis and Poliomyelitis (Inactivated) Vaccine (Adsorbed)*
Diphtheria, Tetanus, Pertussis, Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Vaccine (Adsorbed)*
Radiopharmaceutical Preparations
Raclopride ([11C]Methoxy) Injection*
Sodium Acetate ([1-11C]) Injection*
Technetium (99mTc) Exametazime Injection*
Homoeopathic Preparations
Common Stinging Nettle for Homoeopathic Preparations*
Garlic for Homoeopathic Preparations*