Foreign Matter in Herbal Drugs

A revised version of Ph. Eur. Chapter 2.8.2 Foreign Matter is available in Pharmeuropa 33.3. The comment deadline is 30 September 2021.

Clarification provided for "other foreign matter"

So far, Ph. Eur. chapter 2.8.2 defined foreign matter as material consisting of any or all of the following:

  • foreign organs, i.e. matter coming from the source plant but not defined as the herbal drug;
  • foreign elements, i.e. matter not coming from the source plant and of either vegetable or mineral origin.

In addition, herbal drugs should be free from other foreign matter like moulds, insects and other animal contamination.

Now, the requirements for other foreign matter have been further specified:

  • other foreign matter, i.e. moulds and animal contamination (e.g. insects, their eggs or larvae, spiders, rodents and excreta) and any other unwanted matter (e.g. glass, metal, plastic).

However, it is clarified that the maximum allowed amount of foreign matter that is specified in the general Ph. Eur. monograph Herbal drugs or in an individual monograph, only applies to "foreign organs" and "foreign elements". "Other foreign matter" as defined in the draft chapter is not covered by this limit but should, as far as possible, be absent.

More information can be found in the draft Ph. Eur. chapter 2.8.2 Foreign Matter published in Pharmeuropa Online.

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