23/24 November 2020
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.
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.
According to the USP the following sections will be included in <1567>:
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)".