Among the medicinal preparations now widely used are powders, granules, pills, extracts, tablets and injections. Traditional powders and pills are made of powdered plant materials, tablets, granules, ointments and newer types of pills are mostly made of extracts; injections are made of purified extracts or pure active constituents isolated from the plant material. There are also certain medicinal preparations made of both powdered plant materials and extracts.
Name and formula of the product
• Name in Latin, English and native languages.
• Formula including the name of each ingredient and the quantities used for 1000 g or 1000 ml of the product. A quantity may be given as a range corresponding to a definite quantity of assayed active constituents. Any excipient used should be specified.
• Method of preparation to make 1000 g or 1000 ml of the product. The description of the method should include details of any process, such as solvent used, time and temperature of an extraction and concentration, as well as the process used to reduce the level of microbial contamination.
• The active constituents, as far as they are known, should be stated and their structural formulae given. Any chemical or pharmacological incompatibility should be mentioned.
Authenticity. A description of macroscopic and sensory characteristics should be given and, if powdered plant materials are used as ingredients, their microscopic characteristics should be described together with drawings or pictures. Physical or chemical identification tests should be described and thin-layer chromatographic procedures for the characterizing compounds should be described. A drawing or photograph of the chromatogram should be included. For compound preparations, the most important ingredients including the use of a “finger-print” should be obtained by either thin-layer chromatography or high performance liquid chromatography.
Purity. Limit tests for heavy metals in extracts and the test for freedom from methanol in alcoholic preparations should be specified. Limit tests for contaminants such as microorganisms, mycotoxins and pesticides may be needed.
Assay. The content of biologically or therapeutically active constituents, particularly those which influence the efficacy of the product, should be determined and an acceptable range specified. For herbal mixtures, the most characterizing compounds possible should be assayed.
Tests related to the form of the preparation for both non-clinical and clinical tests should follow any available regulatory requirements of Member States or the World Health Organization guidelines.
Packaging, labelling and storage. The conditions for packaging, labelling and storage should all be recorded.