Herbal Drugs

(Ph Eur monograph 1433)

Ph Eur

Herbal drugs are mainly whole, fragmented, or cut plants, parts of plants, algae, fungi or lichen, in an unprocessed state, usually in dried form but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal drugs. Herbal drugs are precisely defined by the botanical scientific name according to the binominal system (genus, species, variety and author).

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs.

Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations. They are not rotten.

If a decontaminating treatment has been used, it is necessary to demonstrate that the constituents of the plant are not affected and that no harmful residues remain. The use of ethylene oxide is prohibited for the decontamination of herbal drugs.

Herbal drugs are identified using their macroscopic and microscopic descriptions and any further tests that may be required (for example, thin-layer chromatography).

Carry out a test for foreign matter, unless otherwise prescribed or justified and authorised. The content of foreign matter is not more than 2 per cent m/m, unless otherwise prescribed or justified and authorised. A specific appropriate test may apply to herbal drugs liable to be adulterated.

Carry out a test for loss on drying, unless otherwise prescribed or justified and authorised.

A determination of water may be carried out instead of a test for loss on drying for herbal drugs with a high essential-oil content.

Herbal drugs comply with the requirements for pesticide residues. The requirements take into account the nature of the plant, where necessary the preparation in which the plant might be used, and where available the knowledge of the complete record of treatment of the batch of the plant.

Recommendations on the microbiological quality of herbal medicinal products consisting solely of one or more herbal drugs are given in the text 5.1.4. Microbiological quality of pharmaceutical preparations.

Where necessary, herbal drugs comply with other tests, such as the following, for example.

The risk of contamination of herbal drugs by heavy metals must be considered. If an individual monograph does not prescribe a test for heavy metals or specific elements, such a test or tests may be required if justified.

Where necessary, limits for aflatoxins may be required.

In some specific circumstances, the risk of radioactive contamination is to be considered.

Unless otherwise prescribed or justified and authorised, herbal drugs are assayed by an appropriate method.

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