The International Pharmacopoeia, 3E, Vol 3

The International Pharmacopoeia constitutes a collection of recommended methods and specifications that are not intended to have a legal status as such in any country unless expressly introduced for that purpose by appropriate legislation but are offered to serve as reference so that national requir ements can be established on a similar basis in any country. It should be noted that in general the quality of pharmaceutical products cannot be adequately established on the basis of specifications alone and that they should invariably be produced in accordance with Good Manufacturing Practices. Many national or regional pharmacopoeias rely increasingly on complex-techniques of analysis that while time-saving require expensive equipment and highly specialized personnel. These methods are therefore inapplicable in countries lacking such resources. Since The International Pharmacopoeia aims primarily at accommodating the needs of developing countries it offers instead sound simplified and classical chemical methods Moreover the selection of methods is correlated with the WHO recommendations concerning equipment for small and medium-sized drug quality control laboratories.