Herbal Drugs: USP Proposes New General Chapter on PAs

The USP Expert Committee for Botanical Dietary Supplements and Herbal Medicines (BDSHM) proposes to elaborate a new General Chapter <1567> Pyrrolizidine Alkaloids (PAs). The USP is requesting early input from stakeholders (e.g. suppliers of botanical ingredients, dietary supplement manufacturers of botanical products and testing laboratories) on this informational General Chapter. The input deadline is August 30, 2020.

Potential contamination of food supplements and herbal medicines with PAs

PAs and their respective N-oxides are known to be hepatotoxic, carcinogenic, and genotoxic. According to USP, PAs have been identified in more than 6,000 plant species. Many of these plants are common weeds, which can contaminate raw plant materials used for the production of herbal medicinal products (HMPs). Therefore, USP is proposing the development of this general informational chapter "to provide information about the potential for contamination, structures, and toxic characteristics of PAs". Previously the EDQM has already announced to develop a new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids

Preliminary outline of <1567>

According to the USP the following sections will be included in <1567>:

  • Introduction,
  • Structures of PA families,
  • Review of Toxicological data,
  • Limits of PAs,
  • Recommended PAs for monitoring,
  • Suitable analytical procedures used in the quantification of contaminant PAs.

The draft chapter is expected to be published for comment in Pharmacopeial forum (PF) 47(1) [Jan. – Feb. 2021]. More information is provided on USP´s Compendial Notices Website "General Chapter Prospectus: <1567> Pyrrolizidine Alkaloids (PAs)".

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