Processed Herbal Drugs

DEFINITION

Processed Herbal Drugs are obtained by subjecting Herbal Drugs to traditional processing methods.

Processed Herbal Drugs are defined precisely by the botanical scientific name according to the binomial system (genus, species, subspecies, variety, and author) and plant part. Monographs for Processed Herbal Drugs may refer to the relevant monograph for the unprocessed material where the binomial name is given.

PRODUCTION

Processed Herbal Drugs are obtained by subjecting Herbal Drugs to specific types of processing according to traditional processing methods. These traditional processing methods have the potential to alter the physical characteristics and/or chemical constituents of a Herbal Drug. Traditional processing methods may require the addition of processing aids to the herbal drug, for example, honey, vinegar, wine, milk and salt. The additional processing aids used should be of a suitable quality or of pharmacopoeial quality where a monograph exists. The method of traditional processing is provided under the Production section in individual monographs.

IDENTIFICATION

Processed Herbal Drugs are identified using their macroscopical and, where appropriate, microscopical descriptions and any further tests that may be required.

TESTS

A test for foreign matter, Appendix XI D, is carried out, unless otherwise prescribed in the individual monographs.

A specific appropriate test may be prescribed to detect potential contaminants in processed herbal drugs.

If appropriate, the Processed Herbal Drugs comply with other tests, for example, total ash, Appendix XI J, Method II, ash insoluble in hydrochloric acid, Appendix XI K, Method II, extractable matter, swelling index, Appendix XI C and bitterness value, Appendix XI N.

The test for loss on drying, Appendix IX D, is carried out on Processed Herbal Drugs, unless otherwise prescribed in the individual monographs. A determination of water by distillation, Appendix IX C, Method II, is carried out for Processed Herbal Drugs with a high essential oil content.

Processed Herbal Drugs comply with the requirements for pesticide residues, Appendix XI L. The requirements take into account the nature of the Processed Herbal Drugs, 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 Processed Herbal Drugs during cultivation, harvesting and processing. The content of pesticide residues may be determined by the method described in the annex to the general method.

The risk of contamination of Processed Herbal Drugs by heavy metals must be considered. In an individual monograph either a general limit for heavy metals or specific limits for individual heavy metal may be required.

Where necessary limits for specific toxins, for example aflatoxins or ochratoxins, may be applied.

Where processing is carried out to remove or limit specific constituents from the herbal drug a suitable limit test should be carried out.

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

ASSAY

Unless otherwise justified and authorised Processed Herbal Drugs are assayed by an appropriate method.