ABSTRACT
A pharmacopeia is a collection of recommended specifications and other information for therapeutic products, including drug substances (active ingredients), excipients, dosage forms (also called preparations), and other articles. One function of a pharmacopeia is to provide a uniform and public basis on
which to evaluate these therapeutic products, which are used in the practice of medicine and pharmacy. Ingredients and products that fall short of these specifications can be judged unsuitable for commerce. The authority of such a collection is given through the particular regulatory mechanism of the country, as in the United States or Japan, or in a multinational region, as for Europe. The existence of such a body of information allows its citation outside of its originating environment. Thus, reference may be found in the regulations of countries thousands of miles from the primary national or regional audience. Note that for the purposes of this chapter, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals (ICH) definition of a specification as ‘‘a list of tests, associated analytical procedures, and acceptance criteria’’ will be used (1).
