Pharmacopoeia other

Nevertheless, the problem of pellicle formation and eventual fall in dissolution rate is still of concern, as the drug bioavailability may be influenced if there is a severe challenge. There is a report where exposure of phenytoin capsules to high humidities resulted in poor dissolution as well as destruction of clinical efficacy. Moreover, the enzyme test is not official in pharmacopoeias other than USP and the products stand a chance of being recalled, if the normal pharmacopoeial dissolution limits are not met. 

The Commission hcis functions in relation to publication of the British Pharmacopoeia, other compendia, lists of names and other relevant works. 

Melting point determination is a test that is included in most pharmacopoeias. Other thermal... 

The fermentation-derived food-grade product is sold in 50, 80, and 88% concentrations the other grades are available in 50 and 88% concentrations. The food-grade product meets the Vood Chemicals Codex III and the pharmaceutical grade meets the FCC and the United States Pharmacopoeia XK specifications (7). Other lactic acid derivatives such as salts and esters are also available in weU-estabhshed product specifications. Standard analytical methods such as titration and Hquid chromatography can be used to determine lactic acid, and other gravimetric and specific tests are used to detect impurities for the product specifications. A standard titration method neutralizes the acid with sodium hydroxide and then back-titrates the acid. An older standard quantitative method for determination of lactic acid was based on oxidation by potassium permanganate to acetaldehyde, which is absorbed in sodium bisulfite and titrated iodometricaHy. 

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). 

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. 

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-... 

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. 

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... 

Implants are small, sterile cylinders of dmg, inserted beneath the skin or into muscle hssue to provide slow absorption and prolonged achon therapy. This is principally based on the fact that such dmgs, invariably hormones, are almost insoluble in water and yet the implant provides a rate of dissoluhon sufficient for a therapeuhc effect. The British Pharmacopoeia (1993) describes one implant, testosterone. The United States National Formulary (1990) also ineludes oestradiol. Implants are made fiom the pure drug into tablet form by compression or fusion. No other ingredient can be included sinee this may be insoluble or toxie or, most importantly, may influence the rate of drug release. 

Specific details of the sterility testing of parenteral products, ophthalmic and other non-injectable preparations, catgut, surgical dressings and dusting powders will be found in the British and European pharmacopoeias. 

It is policy of the Commission of the European Pharmacopoeia to minimize the use of reference substances/preparations since the production, maintenance and distribution of chemical reference substances is a costly and time-consuming undertaking. Therefore the decision to establish a reference substance shoidd not be taken lightly and consideration should be given to other approaches which could be adopted to avoid the use of reference substances. A number of strategies can be employed to reduce the need for reference substances. 

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. 

The Promochem Group was the first international specialist supplier of certified reference materials (CRMs) and pharmaceutical reference substances used in environmental, medical and trace element analysis. Their experience provides a viewpoint that echoes, reinforces and expands on many of the trends discussed above (Jenks 1997). From the middle of the 1980 s, sales of CRM by Promochem increased between 10 % and 20 % annually, depending on the market sector and application. Since then National and International Metrology Institutes, such as the now privatized U.K. Laboratory of the Government Chemist (LGC), the European and U.S. Pharmacopoeias, the E.U. IRMM and others have recognized that efficient distribution of RMs, backed by available technical support, is as important as production and certification. Thus, they have moved to spread their influence outside their national origins. The Web and e-commerce will continue to grow as major facilitators of better information dissemination and supply of CRMs. 

The types of microorganisms found in various products are Pseudomonas species, including Pseudomonas aeruginosa, Salmonella, species, Staphylococcus aureus, and Escherichia coli. The USP and other pharmacopoeias recommend certain classes of products to be tested for specified microbial contaminants, e.g., natural plant, animal, and some mineral products for the absence of Salmonella species, suspensions for the absence of E. coli, and topically administered products for the absence of P. aeruginosa and S. aureus. Emulsions are especially susceptible to contamination by fungi and yeasts. Consumer use may also result in the introduction of microorganisms. For aqueous-based products, it is therefore mandatory to include a preservative in the formulation in order to provide further assurance that the product retains its pharmaceutically acceptable characteristics until it is used by the patient. 

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