EUROPEAN PHARMACOPOEIA 5.0 Common stinging nettle for homoeopathic preparations

Mother tinctures for homoeopathic preparations are usuallyclear. A slight sediment may form on standing and that isacceptable as long as the composition of the tincture is notchanged significantly.The manufacturing process is defined so that it isreproducible.

Production by maceration. Unless otherwise prescribed,reduce the matter to be extracted to pieces of suitable size,mix thoroughly and extract according to the prescribedextraction 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 liquidsobtained are combined.

Adjustment of the contents. Adjustment of the content ofconstituents may be carried out if necessary, either by addingthe extraction solvent of suitable concentration, or by addinganother mother tincture for homoeopathic preparations ofthe vegetable or animal matter used for the preparation.

IDENTIFICATIONWhere applicable, at least 1 chromatographic identificationtest is carried out.

TESTSThe limits in an individual monograph are set to includeofficial methods of production. Specific limits will apply toeach defined method of production.If the test for relative density is carried out, the test forethanol need not be carried out, and vice versa.

Relative density (2.2.5). The mother tincture forhomoeopathic preparations complies with the limitsprescribed in the monograph.

Ethanol (2.9.10). The ethanol content complies with thatprescribed in the monograph.

Methanol and 2-propanol (2.9.11) : maximum 0.05 percent V/V of methanol and maximum 0.05 per cent V/V of2-propanol, unless otherwise prescribed.

Dry residue (2.8.16). Where applicable, the mother tincturefor homoeopathic preparations complies with the limitsprescribed in the monograph.

Pesticides (2.8.13). Where applicable, the mother tincturefor homoeopathic preparations complies with the test. Thisrequirement is met if the herbal drug has been shown tocomply with the test.

ASSAYWhere applicable, an assay with quantitative limits isperformed.

STORAGEProtected from light. A maximum storage temperature maybe specified.

LABELLINGThe 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.

01/2005:1599

ARSENIOUS TRIOXIDE FORHOMOEOPATHIC PREPARATIONS

Arsenii trioxidumad praeparationes homoeopathicas

As2O3 Mr 197.8

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.

IDENTIFICATIONA. Dissolve 20 mg in 1 ml of dilute hydrochloric acid R,

add 4 ml of water R and 0.1 ml of sodium sulphidesolution R. The resulting yellow precipitate is soluble indilute ammonia R1.

B. Dissolve 20 mg in 1 ml of hydrochloric acid R1, add 5 mlof hypophosphorous reagent R and heat for 15 min on awater-bath. A black precipitate develops.

TESTS

Appearance of solution. A 100 g/l solution in diluteammonia R1 is clear (2.2.1) and colourless (2.2.2,Method II).

Sulphides. Dissolve 1.0 g in 10.0 ml of dilute sodiumhydroxide solution R. Add 0.05 ml of lead acetate solution R.Any colour in the test solution is not more intense than thatin a standard prepared at the same time and in the samemanner using a mixture of 10.0 ml of a 0.015 g/l solution ofsodium sulphide R in dilute sodium hydroxide solution Rand 0.05 ml of lead acetate solution R (20 ppm).

ASSAY

Dissolve 40.0 mg in a mixture of 10 ml of water R and10 ml of dilute sodium hydroxide solution R. Add 10 ml ofdilute hydrochloric acid R and 3 g of sodium hydrogencarbonate R and mix. Add 1 ml of starch solution R andtitrate with 0.05 M iodine.1 ml of 0.05 M iodine is equivalent to 4.946 mg of As2O3.

01/2005:2030

COMMON STINGING NETTLE FORHOMOEOPATHIC PREPARATIONS

Urtica dioicaad praeparationes homoeopathicas

DEFINITIONWhole, fresh, flowering plant of Urtica dioica L.

CHARACTERSMacroscopic characters described under Identification A.The plant causes an itching, burning sensation on the skin.

IDENTIFICATIONA. Common stinging nettle is perennial. The taproot

sends out creeping subterranean rhizomes, more orless 4-angled in transverse section, from which extend

General Notices (1) apply to all monographs and other texts 895

Copper for homoeopathic preparations EUROPEAN PHARMACOPOEIA 5.0

adventious secondary roots and very numerous brownishhairy rootlets. The stipes are erect, generally unbranched,3 mm to 5 mm in diameter and 0.3 m to 1.5 m high, rarelyup to 2.5 m high, 4-angled, greyish-green and covered inshort hairs and stinging hairs.The decussate leaves are 30 mm to 150 mm long and20 mm to 80 mm wide. The petiole is hispid and usuallyslightly less than one-third the length of the lamina. Theleaf blade is ovate, acuminate, cordate or rounded at thebase, and coarsely dentate ; the apical tooth is distinctlylarger than the lateral teeth. The upper side of the leavesis dark green and usually matt, both sides bear shortserried hairs intermingled with long stinging hairs. The2 stipules are linear-subulate and free. The inflorescencesgrowing from the leaf axils are complex, the flowersunisexual, and, particularly in male plants, generallydistinctly longer than the petiole. After shedding theirpollen, male inflorescences are erect at an oblique angleor horizontal ; female inflorescences are pendent whenthe fruit is ripe. All flowers have long stalks. The perianthof the male flowers is divided half-way down into equalgreen lobes, widest at their base, with short bristles andstinging hairs at the margins. The stamens are equal andopposite to the perianth segments, each with a long,whitish filament that curves inwards before pollen is shedand spreads out afterwards. The ovary is rudimentary,button or cup-shaped. The perianth of the female flowersis downy or bristly on the outside and consists of outer,and 2 inner segments ; the inner segments are abouttwice the length of the outer ones. The hypogynous,ovate, unilocular ovary bears a large capitate stigma witha brush-like shock of hair. As the one-seeded fruit growsripe, the 2 inner segments of the perianth fold aroundit like wings.

B. It complies with the test for Urtica urens (see Tests).

TESTS

Urtica urens. The margin of the lamina is not serrate withteeth twice as long as wide. The clusters of flowers in theaxils are longer than the petiole of the leaf. Unisexual,apetalous flowers are not together on the same plant and inthe same cluster.

Foreign matter (2.8.2) : maximum 5 per cent.Loss on drying (2.2.32) : minimum 65.0 per cent, determinedon 5.0 g of finely cut drug by drying in an oven at 100-105 Cfor 2 h, if performed to demonstrate the freshness of thedrug.

Mother tinctureThe mother tincture complies with the requirements of thegeneral monograph on Mother tinctures for homoeopathicpreparations (2029).

PRODUCTIONThe mother tincture of Urtica dioica L. is prepared bymaceration using alcohol of a suitable concentration.

CHARACTERSAppearance : greenish-brown or orange-brown liquid.

IDENTIFICATIONThin-layer chromatography (2.2.27).Test solution. The mother tincture to be examined.Reference solution. Dissolve 10 mg of phenylalanine Rand 10 mg of serine R in a mixture of equal volumes ofmethanol R and water R and dilute to 10 ml with the samemixture of solvents.

Plate : TLC silica gel plate R.Mobile phase : glacial acetic acid R, water R, acetone R,butanol R (10:20:35:35 V/V/V/V).Application : 20 l, as bands.Development : over a path of 10 cm.Drying : in air.Detection : spray with a 1 g/l solution of ninhydrin R inalcohol R. Heat the plate at 105-110 C for 5-10 min thenexamine in daylight within 10 min.Results : see below the sequence of the zones present in thechromatograms obtained with the reference solution andthe test solution.

Top of the plate

_______ _______

Phenylalanine : a violet toreddish-brown zone

4 red to violet zones

_______ _______

Serine : a reddish-violet zone A violet zone

A violet zone

Reference solution Test solution

TESTS

Relative density (2.2.5) : 0.930 to 0.950.Ethanol (2.9.10) : 40 per cent V/V to 56 per cent V/V.Dry residue (2.8.16) : minimum 1.1 per cent.

01/2005:1610

COPPER FOR HOMOEOPATHICPREPARATIONS

Cuprum ad praeparationes homoeopathicas

Cu Ar 63.5

DEFINITION

Content : 99.0 per cent to 101.0 per cent of Cu.

CHARACTERS

Appearance : reddish-brown powder.Solubility : practically insoluble in water, soluble inhydrochloric acid and in nitric acid, practically insoluble inalcohol.

IDENTIFICATIONA. To 2 ml of solution S (see Tests) add 0.5 ml of potassium

ferrocyanide solution R. A reddish-brown precipitate isformed.

B. To 5 ml of solution S add 0.6 ml of ammonia R. A blueprecipitate is formed. Add 2 ml of ammonia R. Theprecipitate disappears ; the solution has an intense bluecolour.

TESTS

Solution S. Dissolve 2.0 g in 10 ml of nitric acid R. Afternitrous fumes are no longer evolved, dilute to 60 ml withdistilled water R.

Acidity or alkalinity. To 5.0 g add 20 ml of carbondioxide-free water R. Boil for 1 min. Cool. Filter and diluteto 25.0 ml with carbon dioxide free water R. To 10 ml ofthe solution add 0.1 ml of bromothymol blue solution R1.

896 See the information section on general monographs (cover pages)