British Pharmacopoeia Chemical

BPCRS = British Pharmacopoeia Chemical Reference Substance,... 

The BP Commission can also call on expertise available in the British Pharmacopoeia laboratories situated in the premises of the Laboratory of the Government Chemist in West London. The BP laboratory carries out and validates assay procedures for the Commission and in addition, is responsible for the procurement, establishment, maintenance and sale of British Pharmacopoeia Chemical Reference Substances (BPCRS). These reference substances, as their name suggests, are authentic samples of a drug or decomposition product which are used as standards in a drug assay. The BP laboratory also fulfils an important forensic role in the control of counterfeit medicines. With the advent of the internet, the public can easily gain access to supplies of prescription-only medicines online. These medicines are often adulterated, contaminated or simply counterfeit, and comparison with authentic samples is necessary to ensure that the correct preparation is supplied. 

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. 

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). 

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. 

We searched the British Pharmacopoeias 1980 [ 1 ] and 1988 [2] for all drugs which carry a protection from light warning and these were programmed into a C.A.S. on-line search which covered Chemical Abstracts from 1967 to the end of 1988 to form the basis for the review. (Little of this work was done before... 

This chapter will look at the composition of a number of popular aromatherapy materials. There is a lot of published data describing chemical compositions. This can be found in varying degrees of complexity in the aromatherapy books and, additionally, from a number of bodies such as ISO (International Organization for Standardization), RIFM (Research Institute for Fragrance Materials), IFRA (International Fragrance Association), AFNOR (Association Franchise de Normalisation) and the BP (British Pharmacopoeia). 

Authentic IR reference spectra covering the range 2000-500 cm are published in conjunction with monographs for substances of the British Pharmacopoeia (BPC, London). They are also supplied by the European Pharmacopoeia EDQM, Strasbourg) for a more limited number of official substances, where the cost, or toxicity, of a suitable chemical Reference Substance, or restrictions on its supply by post, favour identification by comparison with an official Reference Spectrum. The International Pharmacopoeia (WHO Collaborating Centre for International CRS, Stockholm) will supply on request paper or electronic copies of an authentic Reference Spectrum covering the full mid-IR range, i.e. 4000-600 cm . ... 

An interesting example is die assay of clonidine hydrochloride in injections and tablets (British Pharmacopoeia, 1980). In 0.01 Mhydrochloric acid, clonidine exhibits two sharp maxima ne - 272 nm and 279 nm, which are not suitable for precise measurement. However, clonidine forms an ion pair with bromothymol blue, and this can be readily extracted into chloroform for subsequent measurement of the broad maximum near 420 nm. Because of the intiinsic variabihty of reagents used in such methods, a pharmacopoeial reference standard is employed for cahbration. A similar policy is adopted for assays involving chemical modification of the drug, as in the tetrazolium assay for corticosteroids, the assay for folic acid involving hydrolysis, diazotisation, and coupling with N-(l-naphthyl)ethylenediamine, and the reaction of penicillins with imidazole and mercuric salts. 

The solubility of a solute in a solvent can be expressed quantitatively in several ways (see Chapters, section 3.1). Other less-specific forms of noting solubility include parts per parts of solvent (for example, parts per million, ppm). The British Pharmacopoeia and other chemical and pharmaceutical compendia frequently use this form and also the... 

Purification by treatment with wood charcoal is also employed, the effect is mainly a chemical one due to oxidation. This filtration may either precede or follow a rectification by distillation. The Spiritus Rectificaius or Alcohol (90 per ceut.) of the British Pharmacopoeia is defined as a mixture of ethyl hydroxide and water containing m 100 parts by volume, 90 parts by volume of ethyl hydroxide, C2H5OH. Specific gravity 0-8337. It contains 85-68 per cent, by weight of ethyl hydroxide, and 14-32 per cent, by weight of water. 

The term quality control is used differently around the world. In the Far East, particularly Japan, it refers to what the Western industrial nations call quality assurance (QA), which is discussed shortly. QC in the West refers to the process of monitoring the product to establish whether or not it conforms to specified requirements, for example to demonstrate that a manufactured batch of a chemical used as a pharmaceutical raw material meets all the requirements of the specification published in the British Pharmacopoeia. In fact, this is not true QC, other than to prevent the release and use of substandard product. It only assesses quality, after the process is complete, and this is both costly and of limited operational use. In the analytical laboratory, QC refers to the analyses conducted along with a batch of samples, the results of which are used to judge whether the analyses were made correctly. For this... 

Commercial essential oils are required to comply with sets of standards and specifications published by standards organizations such as International Standards Organization (ISO), British Standards, Essential Oil Association of USA, American Society for Testing and Materials, German DIS Standards, French AFNOR Standards, and so on, or pharmacopoeias or codices such as European Pharmacopoeia (Pharm. Eur.) (see Table 9.2 (29)), British Pharmacopoeia (BP), Deutsche Arzneibuch, Pharmacopoeia of the United States (USP), Food Chemicals Codex, Codex Alimentarius, and so on (1, 4, 6, 10). A full list of essential oil standards can be obtained from ISO (30). 

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