EUROPEAN PHARMACOPOEIA 5.

Common stinging nettle for homoeopathic preparations

Mother tinctures for homoeopathic preparations are usually clear. A slight sediment may form on standing and that is acceptable as long as the composition of the tincture is not changed significantly. The manufacturing process is defined so that it is reproducible. Production by maceration. Unless otherwise prescribed, reduce the matter to be extracted to pieces of suitable size, mix thoroughly and extract according to the prescribed extraction method with the prescribed extraction solvent. Allow to stand in a closed vessel for the prescribed time. The residue is separated from the extraction solvent and, if necessary, pressed out. In the latter case, the 2 liquids obtained are combined. Adjustment of the contents. Adjustment of the content of constituents may be carried out if necessary, either by adding the extraction solvent of suitable concentration, or by adding another mother tincture for homoeopathic preparations of the vegetable or animal matter used for the preparation. IDENTIFICATION Where applicable, at least 1 chromatographic identification test is carried out. TESTS The limits in an individual monograph are set to include official methods of production. Specific limits will apply to each defined method of production. If the test for relative density is carried out, the test for ethanol need not be carried out, and vice versa. Relative density (2.2.5). The mother tincture for homoeopathic preparations complies with the limits prescribed in the monograph. Ethanol (2.9.10). The ethanol content complies with that prescribed in the monograph. Methanol and 2-propanol (2.9.11) : maximum 0.05 per cent V/V of methanol and maximum 0.05 per cent V/V of 2-propanol, unless otherwise prescribed. Dry residue (2.8.16). Where applicable, the mother tincture for homoeopathic preparations complies with the limits prescribed in the monograph. Pesticides (2.8.13). Where applicable, the mother tincture for homoeopathic preparations complies with the test. This requirement is met if the herbal drug has been shown to comply with the test. ASSAY Where applicable, an assay with quantitative limits is performed. STORAGE Protected from light. A maximum storage temperature may be specified. LABELLING The label states : that the product is a mother tincture for homoeopathic preparations (designated as "TM" or ""), the name of the raw material using the Latin title of the European Pharmacopoeia monograph where one exists, the method of preparation, the ethanol content or other solvent content, in per cent V/V, in the mother tincture, the ratio of raw material to mother tincture, where applicable, the storage conditions. General Notices (1) apply to all monographs and other texts

01/2005:1599

ARSENIOUS TRIOXIDE FOR HOMOEOPATHIC PREPARATIONS Arsenii trioxidum ad praeparationes homoeopathicas

As2O3 DEFINITION Content : 99.5 per cent to 100.5 per cent of As2O3. CHARACTERS Appearance : white or almost white powder. Solubility : practically insoluble to sparingly soluble in water. It dissolves in solutions of alkali hydroxides and carbonates. IDENTIFICATION A. Dissolve 20 mg in 1 ml of dilute hydrochloric acid R, add 4 ml of water R and 0.1 ml of sodium sulphide solution R. The resulting yellow precipitate is soluble in dilute ammonia R1. B. Dissolve 20 mg in 1 ml of hydrochloric acid R1, add 5 ml of hypophosphorous reagent R and heat for 15 min on a water-bath. A black precipitate develops. TESTS Appearance of solution. A 100 g/l solution in dilute ammonia R1 is clear (2.2.1) and colourless (2.2.2, Method II). Sulphides. Dissolve 1.0 g in 10.0 ml of dilute sodium hydroxide solution R. Add 0.05 ml of lead acetate solution R. Any colour in the test solution is not more intense than that in a standard prepared at the same time and in the same manner using a mixture of 10.0 ml of a 0.015 g/l solution of sodium sulphide R in dilute sodium hydroxide solution R and 0.05 ml of lead acetate solution R (20 ppm). ASSAY Dissolve 40.0 mg in a mixture of 10 ml of water R and 10 ml of dilute sodium hydroxide solution R. Add 10 ml of dilute hydrochloric acid R and 3 g of sodium hydrogen carbonate R and mix. Add 1 ml of starch solution R and titrate with 0.05 M iodine. 1 ml of 0.05 M iodine is equivalent to 4.946 mg of As2O3. 01/2005:2030 Mr 197.8

COMMON STINGING NETTLE FOR HOMOEOPATHIC PREPARATIONS Urtica dioica ad praeparationes homoeopathicas
DEFINITION Whole, fresh, flowering plant of Urtica dioica L. CHARACTERS Macroscopic characters described under Identification A. The plant causes an itching, burning sensation on the skin. IDENTIFICATION A. Common stinging nettle is perennial. The taproot sends out creeping subterranean rhizomes, more or less 4-angled in transverse section, from which extend 895