Pharmacopoeia: British

These white oils are subject to specifications from various organizations Codex in France, British Pharmacopoeia" (BP) in the United Kingdom, and National Formulary (NF) in the USA. 

Bureau de Normalisation du Petrole British Pharmacopoeia boiling point... 

The British Pharmacopoeia specifies a biological assay for the sodium salt of rifamycia SV [14897-39-3]. It also specifies a spectrophotometric assay for rifampicia (201). The United States Pharmacopeia requires an hplc assay for rifampin (202). 

British Pharmacopoeia 1988, Hei Majesty s Stationery Office, London, 1988, pp. 493—494. 

There are a variety of analytical methods commonly used for the characterization of neat soap and bar soaps. Many of these methods have been pubUshed as official methods by the American Oil Chemists Society (29). Additionally, many analysts choose United States Pharmacopoeia (USP), British Pharmacopoeia (BP), or Pood Chemical Codex (FCC) methods. These methods tend to be colorimetric, potentiometric, or titrametric procedures. However, a variety of instmmental techniques are also frequendy utilized, eg, gas chromatography, high performance Hquid chromatography, nuclear magnetic resonance spectroscopy, infrared spectroscopy, and mass spectrometry. 

Grease Refining and Fractionation. Lanolin to be used in pharmaceuticals and cosmetics must conform to strict requirements of purity, such as those in the U.S. and British Pharmacopoeias (181,182). These include specifications for the maximum allowable content of free fatty acids, moisture, ash, and free chloride. Lanolin intended for certain dermatological appHcations may have to meet further specifications in relation to free-alcohol and detergent contents (183,184). 

British Pharmacopoeia, Her Majesty s Stationary Office, London, 1980. 

In the known absence of bromoform, iodoform, chloral, and other halogenated methanes, the formation of phenyhsonitrile with aniline provides a simple and faidy sensitive but nonspecific test for the presence of chloroform, the carbylamine test. Phenyhsonitrile formation is the identification test given in the British Pharmacopoeia. A small quantity of resorcinol and caustic soda solution (10% concentration) added to chloroform results in the appearance of a yellowish red color, fluorescing yeUow-green. When 0.5 mL of a 5% thymol solution is boiled with a drop of chloroform and a small quantity of potassium hydroxide solution, a yellow color with a reddish sheen develops the addition of sulfuric acid causes a change to brilliant violet, which, diluted with water, finally changes to blue (33). 

An entirely different type of contamination arises from the presence of microbiota in a product. As in the case of chemical contamination, compendial requirements for microbiological purity exists. Pharmacopoeial standards vary from country to country, and manufacturers must use the specifications and kill times that meet local requirements. As of this writing, the criteria in the British Pharmacopoeia are more stringent than those estabUshed by the CTFA, which are stricter than those in the United States Pharmacopoeia. In order to meet commonly accepted standards of microbial purity, manufacturing faciUties must be periodically cleaned and all products that can support microbial growth must contain an effective preservative (6). 

Atropa acuminata Royle ex Lindl. (A. lutescens Jacquemont.) Indian belladonna. Whole plant, grown from Indian seed in the United States, 0-32 to 0-38 large stems, 0-14, According to Corfield, Kassner and Collins,the leaves and roots, as imported from India, contain on the average 0-45 and 0-47 of non-volatile alkaloid, respectively. Much volatile alkaloid (MarkwelUi). Recognised in the British Pharmacopoeia 1932, Addendum V. 

The British Pharmacopoeia (1932) recognises three of these solanaceous drugs and specifies for them minimum requirements per cent, of total alkaloids, calculated as hyoscyamine, viz. belladonna, leaves 0-3, root 0-4 henbane, leaves and flowering tops 0-05 stramonium, leaves and flowering tops 0-25. The United States Pharmacopoeia, XIII, specifies the same minimum limits for belladonna leaves and stramonium and for henbane, 0-04. 

For use in medicine, opium is dried, powdered and standardised to a definite content of morphine, which the British Pharmacopoeia 1932 places at 10 per cent, (limits 9-5 and 10-5), and the United States Pharma-copceia (XIII) at not less than 10 or more than 10-5 per cent. 

A method for the estimation of the total alkaloids and of non-phenolic alkaloids (emetine fraction) is given in the British Pharmacopoeia, 1932, Addendum VI, which requires the drug to contain not less than 2 per cent, of alkaloids, of which at least 55 per cent, must be non-phenolic bases, calculated as emetine. The British Pharmacopoeia also gives an assay process for emetine in emetine bismuth iodide, the form in which the drug is chiefly used in medicine it is required to contain not less than 25 and not more than 28 per cent, of emetine. In the United States Pharmacopoeia, XIII, both Cephcelis Ipecacuanha and C. acuminata are recognised and must contain not less than 2 per cent, of ether-soluble alkaloids. 

Analyses of Cinchona Barks. For galenical preparations, pharmacopoeia recognition is usually restricted to barks of cultivated cinchona species known to yield total alkaloids satisfactory in composition thus, the British Pharmacopoeia 1932 prescribes the varieties to be used, and specifies not less than 6 per cent, of total alkaloids, of which at least half must be quinine and cinchonidine, determined by the process prescribed. Numerous other processes have been published and references to the more important of these are given under the following headings —identifica-... 

For the separate determination of the four principal components in the total alkaloids, the method in general use is based on the isolation of quinine and cinchonidine as d-tartrates, of cinchonine as the base in virtue of its sparing solubility in ether, and of quinidine as the hydriodide. Types of this method have been described by Chick, and special modifications designed for use in the analysis of totaquina are given in the British Pharmacopoeia 1932 and in a special report by the Malaria Commission of the League of Nations. Goodson and Henry have critically examined this process and shown that, with care, it gives satisfactory... 

The barks of Alstoiiia species (Apocyiiaceae) had a considerable reputation throughout the tropics as effective anti-malarial drugs, which led to their inclusion in the British Pharmacopoeia, 1914, and to their chemical examination by various workers. The following is a list of the species examined and of the alkaloids found. The figures in brackets are percentages of total alkaloids. 

Baker and Smith have devised an improved rapid method which they find works well with oils containing 20 per cent, and over. Eucalyptus oils which give a compound that cannot be satisfactorily pressed by the British Pharmacopoeia method may be readily determined in this way and the decomposition of the cineol phosphate by long pressing (particularly in hot countries) is prevented. 

This method has been examined carefully and it appears to be more accurate than the phosphoric acid method as set on in the British Pharmacopoeia and likely to give practically identical results in different hands and under different atmospheric conditions. ... 

It should be emphasised, however, that, as the cresol method gives higher results than the B.P. method, a minimum of 60 or even 65 per cent, cineol should be required if the new method is made official in the British Pharmacopoeia. 

TSie processes depending on the use of sodium bisulphite or sulphite, and in which the aldehyde or ketone compounds dissolve in the solution of the reagent, are known as absorption processes, and are those most commonly employed for oils containing a high proportion of aldehydes and ketones, the use of sodium bisulphite being probably still the method most usually adopted for aldehydes, though the use of neutral sodium sulphite is the official process in the British Pharmacopoeia of 1914, and is also that most suitable for the estimation of ketones. 

Purified Pharmaceuticals United States Pharmaceopeia (USP) British Pharmacopoeia (BP)... 

The varying metabolic activities of bacteria and their response to immediate environmental factors have been exploited in the design of special diagnostic and selective media. Recipes for these run into many hundreds such media are used in hospital and public health laboratories for identifying organisms found in samples believed to be contaminated by them, and as an aid to diagnosis and treatment. In addition they are used to detect contaminants in pharmaceutical products (British Pharmacopoeia 1993). A few examples will be given to illustrate the principle. 

In media selective for enterobacteria a surface-active agent is the main selector, whereas in staphylococcal medium sodium and lithium chlorides are the selectors staphylococci are tolerant of salt concentrations to around 7.5%. Mannitol salt, Baird-Parker (BP) and Vogel-Johnson (VJ) media are three examples of selective staphyloccocal media. Beside salt concentration the other principles are the use of a selective carbon source, mannitol or sodium pyruvate together with a buffer plus acid-base indicator for visualizing metabolic activity and, by inference, growth. BP medium also contains egg yolk the lecithin (phospholipid) in this is hydrolysed by staphylococcal (esterase) activity so that organisms are surrounded by a cleared zone in the otherwise opaque medium. The United States Pharmacopeia (1990) includes a test for staphylococci in pharmaceutical products, whereas the British Pharmacopoeia (1993) does not. 

Different performanee eriteria are laid down for injeetable and ophthahrtic preparations, topical preparations and oral hquid preparations. Inhibition of the challenge organism is determined by viable coimting teehniques. The British Pharmacopoeia (1993) should be eonsulted for full details of the experimental procedures to be used. 

British Pharmacopoeia (1993) London Her Majesty s Stationery Office. (The British Pharmacopoeia contains edited versions of the monographs for immunological products that appear in the European Pharmacopoeia.)... 

Recognizing these problems, UK food regulatory authorities have generally abandoned the use of quantitative microbial counts as enforceable standards of food quality. Despite this, the European Pharmacopoeia has introduced both quantitative and qualitative mierobial standards for non-sterile medicines, which might become enforceable in some member states. It prescribes varying maximum total microbial levels and exclusions of particular species according the routes of administration. The British Pharmacopoeia has now ineluded these tests, but suggest they should be used... 

British Pharmacopoeia (1993) Appendix KV C Efficacy of Antimicrobial Preservation, A191-A192, (and BP 1993, 1995 Addendum Appendix XVIIF, A407). London HMSO. (3.2)... 

British Pharmacopoeia (1993) (1996 Addendum) Introduction Microbial Contamination, ixxxiii, and Appendix XVI D Microbial Quality of Pharmaceutical Preparations, A519. London HMSO. (3.4)... 

The British Pharmacopoeia (1993) recognizes five methods for the sterilization of pharmaceutical products. These are (i) dry heat (ii) heating in an autoclave (steam sterilization) (iii) filtration (iv) ethylene oxide gas and (v) gamma or electron radiation. In addition, other approaches involving steam and formaldehyde and ultraviolet (UV) light have evolved for use in certain situations. For each method, the possible permutations of exposure conditions are numerous, but experience and product stability... 

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