The Pharmacopoeia

The role of the European, U. S. and other pharmacopoeia in the production, certification and use of reference substances has already been described. Section 5.5 reviewed the processes and techniques used by the European pharmacopoeia in their production of reference substances. The main pharmacopoeias maintain comprehensive web sites and issue publications describing their activities, but as they are not yet a main part of the ISO REMCO community, it is necessary to visit their websites for further information. 

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The Pharmacopoeia of Japan, The Society of Japanese Pharmacopoeia, Tokyo, Japan, 1987. 

The definitions coarsely chopped to finely powdered , which formerly in the pharmacopoeias were given as mesh sizes, are mostly nowadays indicated without such a requirement in the DAB 10, V. 4.N6, only coarsely chopped (4000 to 2800 sieve), finely chopped (2000 sieve), and powdered (710 to 180 sieve) are distinguished. The wide particle-size ranges have rightly been criticized [1, 2], partly on the basis of extensive investigations. 

Assuming that herbal drugs are going to be used medicinally, the same care will be taken regarding their storage and packaging as with any other medicine. There are not many indications to be found in the pharmacopoeias as to how drugs should be stored. 

The present chapter, therefore, will present certain topics based on a selection of references, mainly in view of providing a perception of the current developments and great potential of chitin today. The reader is referred to books and reviews [1-17] where basic information and specific subjects are treated in a more systematic way. These polysaccharides are described not only in encyclopaedias, handbooks, monographs and articles, but also in the American Standard Testing Materials standard guides and in the Pharmacopoeias of various coimtries [10,16,17]. 

Pharmacopoeial standards and substances are established and distributed by pharmacopoeial authorities following the general principles of this Guide. It should be noted, however, that a different approach is used by the pharmacopoeial authorities to give the user the information provided by certificates of analysis and expiration dates. Also, the uncertainty of their assigned values is not stated since it is negligible in relation to the defined limits of the method-specific assays of the pharmacopoeias for which they are used. ... 

It is to be hoped that in the future there may be greater harmonization between the pharmacopoeia monographs leading to a greater number of common reference substances or standards. 

When developing an analytical method to meet the requirements of being validatable, the burden is on the developer of the method to show that it is, in fact, suitable for its intended purpose . The Pharmacopoeia and ICH specifications include a laundry... 

Similarly, well before Lavoisier, in London in the mid-eighteenth century, the Royal College of Physicians convened the Pharmacopoeia Committee, which adopted the principle that names of compounds should be related to their constituents rather than to their observable properties or to analogies with things like butter and flowers. The physicians 1746 dictionary of names influenced Macquer s 1766 dictionary of chemistry. 43... 

The Offlcal Standards, as stipulated in the pharmacopoeias of various countries, e.g., IP BP, Em. R, Int. P, USSRP, JP etc., of a pharmaceutical substance take cognizance of the purity, nature, methods and hazards of manufacture, precautions of storage and ultimately the conditions under which the product is to be used. 

Weight per millilitre is prevalent in the Pharmacopoeia of India for the control of liquid substances, whereas Relative Density (20720°) or Specific Gravity is mostly employed in the European Pharmacopoeia. 

Specifically for the synthetic organic compounds, the Pharmacopoeia prescribes values for sulphated ash. The sulphated ash is determined by a double ignition with concentrated sulphuric acid. Metals thus remain as sulphides that are usually stable to heat. The method is one of some precision, and provides results which are rather more reproducible than those obtained by simple ignition. 

Pharmaceutical chemicals belonging to the domain of inorganic as well as organic substances containing readily volatile matter for which the various official compendia prescribe limits of non-volatile matter. It is pertinent to mention here that the Pharmacopoeia usually makes a clear distinction between substances that are readily volatile and substances that are volatile upon strong ignition, for instance ... 

In short, all prescribed tests for impurities in the Pharmacopoeia usually fix certain limits of tolerance. For lead, arsenic and iron general quantitative or limit tests are precisely laid down which, with necessary variations and modification are rigidly applicable to pharmaceutical substances. 

The details of experimental procedure described in the Pharmacopoeia are actually based upon a paper by Hill and Collins, but have been adequately modified from time to time in accordance with the accumulated and acquired experience. Explicitly, the expressions provided in the Pharmacopoeia for limits of arsenic exclusively refer to parts per million, calculated as As. 

Acid radical impurities constitute a serious but unavoidable source of impurities in a large number of pharmaceutical chemicals. However, the two most commonly found acid radical impurities are chloride (Cl ) and sulphate (S042 ) that evidently arise from the inevitable use of raw tap-water in various manufacturing operations. As these two acid radical impurities are found in abundance due to contamination, the Pharmacopoeia categorically stipulates limit tests for them which after due minor modifications are applicable to a number of pharmaceutical substances. 

Examples of a few official compounds subject to this test from the Pharmacopoeia are given below ... 

The quantities as specifed in the Pharmacopoeia allow an official limit of nitrate equivalent to about 0.29% BiON03. 

A few typical examples of acidimetric titrations, employing direct titration method (DTM) and residual titration method (RTM) from the Pharmacopoeia of India are described here ... 

The optical rotation of a number of substances official in the pharmacopoeia may be determined conveniently as stated in Table 19.1. 

Following is the detailed procedure laid out in the Pharmacopoeia of India (IP) for the preparation of KBr-disc or KCl-disc ... 

In the meantime, dissolution testing was more and more standardized and gained enormous impact on the fields of quality assurance and drug development in pharmaceutical industry. Several dissolution apparatus made then-way into the pharmacopoeiae, such as the rotating paddle, rotating bas-... 

Existing active substances not described in the European Pharmacopoeia, but described in the pharmacopoeia of a member state... 

PP/IIR-V is marketed to compete with conventional butyl rubber thanks to its low gas permeability, compliance with the pharmacopoeia and, secondarily, its damping properties. 

PP/IIR-V is appreciated for its low gas permeability combined with compliance with the pharmacopoeia, fair compression sets, the rubber-like hardness range, low density, low-temperature behaviour, fair ageing resistance, sterilization resistance, damping properties, ease of waste recycling... 

Various international pharmacopoeias help assure the quality of drugs worldwide. These pharmacopoeias constantly review and revise their monographs. A different impurity profile can be anticipated if a drug s production process is changed this results in the development of new analytical methods that need to be incorporated in the pharmacopoeias. In earlier editions, color reactions were performed for identification and purity evaluation purposes. 

Nowadays, the pharmacopoeias make use of chromatographic methods and try to replace less sensitive TLC methods with HPLC tests. However, CE methods are rarely used even though they can at times he more useful than HPLC for determining the impurity evaluation of a drug (Chapter 11). CE is currently used, especially in the case of peptides and proteins, in the EP and the USP. These methods and perspectives for new applications are given in the same Chapter. 

As a result of the pharmacopoeial harmonization process, general chapter 2.2.47. of the Ph.Eur. and general chapter 8 of the JP (Capillary Electrophoresis) and general chapter < 1047) of the USP (Biotechnology-Derived Articles — Tests, Capillary Electrophoresis ) have been harmonized to a major extent. At present some minor differences exist between the text and a few equations in the pharmacopoeia. In these chapters, the following definition of CE is given ... 

Considering the tremendous progress CE and related techniques have made in the last years the behavior of the authorities is difficult to understand because there is still a need of highly selective and sensitive methods for quality assessment of drugs and CE can contribute to the issue on a very high level. As already mentioned above every new technique needed time to find their way into the pharmacopoeias therefore, there is still a chance for CE. 

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