[Characterization of plant extracts and registration requirements]

The extracts of vegetable origin, obtained by extraction, pressing and subsequent processing from whole plants or from their fresh or dried parts, contain the active principles in admixture with secondary constituents in the natural ratio. The quali-quantitative characterization of such extracts, as active ingredients for the formulation of proprietary medicinal products, requires therefore, if compared with that of pure products, to set up a specific analytical development in relation to the complexity and the grade of refinement attained by the multicomponent mixture. In respect of the existing European Community provisions for the control of pharmaceutical starting materials, the problems relevant to nomenclature, description, manufacture and quality control for the scientific documentation of the various extracts, are discussed in comparison with those of pure products.