Mother Tinctures for Homoeopathic Preparations

(Ph. Eur. monograph 2029)

Ph Eur

Mother tinctures for homoeopathic preparations are liquid preparations obtained by the solvent action of a suitable vehicle upon raw materials. The raw materials are usually in the fresh form but may be dried. Mother tinctures for homoeopathic preparations may also be obtained from plant juices, with or without the addition of a vehicle. For some preparations, the matter to be extracted may undergo a preliminary treatment.

Mother tinctures for homoeopathic preparations are prepared by maceration, digestion, infusion, decoction, fermentation or as described in the individual monographs, usually using alcohol of suitable concentration.

Mother tinctures for homoeopathic preparations are obtained using a fixed proportion of raw material to solvent, taking the moisture content of the raw material into account, unless otherwise justified and authorised.

If fresh plants are used, suitable procedures are used to ensure freshness. The competent authorities may require that the freshness is demonstrated by means of a suitable test.

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.

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 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.

Where applicable, at least 1 chromatographic identification test is carried out.

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.

The mother tincture for homoeopathic preparations complies with the limits prescribed in the monograph.

The ethanol content complies with that prescribed in the monograph.

Maximum 0.05 per cent V/V of methanol and maximum 0.05 per cent V/V of 2-propanol, unless otherwise prescribed.

Where applicable, the mother tincture for homoeopathic preparations complies with the limits prescribed in the monograph.

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.

Justification is provided in cases where the test for pesticides is performed on the mother tincture, instead of on the herbal drug according to the requirements of the general monograph Herbal drugs for homoeopathic preparations (2045). Limits will be set, taking into consideration the nature and the origin of the herbal drug. The dilution factor of the mother tincture and the limit of detection of the method are also taken into account when fixing these limits.

Justification is provided in cases where the test for heavy metals is performed on the mother tincture, instead of on the herbal drug according to the requirements of the general monograph Herbal drugs for homoeopathic preparations (2045). Limits will be set, taking into consideration the nature and the origin of the herbal drug. The dilution factor of the mother tincture and the limit of detection of the method are also taken into account when fixing these limits.

If required by the competent authority, suitable limits for the content of other heavy metals such as arsenic or nickel may be defined.

Where applicable, an assay with quantitative limits is performed.

Protected from light. A maximum storage temperature may be specified.

• — that the product is a mother tincture for homoeopathic preparations (designated as 'TM' or 'Ø');

• — 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.

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