15/16 November 2023
The European Pharmacopoeia (Ph. Eur.) Commission recently adopted the previously announced general chapter on Contaminant pyrrolizidine alkaloids (2.8.26). Early adoption of the new chapter was reached following reports in some Ph. Eur. member states that herbal medicinal products (HMPs) had been found to be contaminated with traces of plants containing toxic pyrrolizidine alkaloids (PAs).
The new Ph. Eur. chapter 2.8.26 has been published for comment in Pharmeuropa (32.1). The general chapter allows for the use of any procedure consisting of chromatography coupled with MS / MS or high resolution MS that meets the validation requirements. According to the Ph. Eur. commission, the approach was adopted "because there is considerable variation in the composition and matrices of herbal drugs, herbal drug preparations and HMPs concerned, as well as in the applicable limits, making it difficult to describe all the methods suitable for quantitative analysis of the target PAs". However, the analytical procedure provided in 2.8.26 has been shown to be suitable for the determination of 28 target PAs in a number of matrices.
The chapter will be published in Ph. Eur. Supplement 10.6 on 1 July 2021 with an implementation date of 1 January 2022. For more information please read the announcement on the EDQM website.
In 2020, the Herbal Medicinal Products Committee (HMPC) of the EMA has published a draft of the updated public statement on PAs. The statement contains, among other things, the proposed limit values for the daily maximum intake of PAs. For contamination of medicinal products with PAs a limit of max. 1.0 µg per day for adults would apply (oral use). This limit was also mentioned in the draft for the new Ph. Eur. chapter 2.8.26.
The United States Pharmacopeia (USP) is currently also developing a new chapter <1567> Pyrrolizidine Alkaloids together with a new chapter entitled <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs).