At its 168th session in November 2020, the European Pharmacopoeia Commission adopted the new general chapter Contaminant pyrrolizidine alkaloids (2.8.26).
The adoption of this new chapter addresses the demands of European regulators following reports in some Ph. Eur. member states that herbal medicinal products (HMPs), as well as foods, had been found to be contaminated with traces of plants containing pyrrolizidine alkaloids (PAs).
The acute toxicity, genotoxicity and carcinogenic potential of PAs have been known for decades. Patient exposure to PAs from HMPs should be as low as possible and must not exceed the maximum daily intake agreed by the competent authority.
This general chapter, which describes 28 target PAs, allows for the use of any procedure consisting of chromatography coupled with MS/MS or high resolution MS that meets the validation requirements given in the chapter. This approach was adopted because there is considerable variation in the composition and matrices of the 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.
Moreover, as an example, this general chapter describes an analytical procedure that has been shown to be suitable for the determination of the 28 target PAs in a number of matrices. In addition, it provides verification requirements analysts may need to meet when it is necessary to demonstrate that the analytical procedure used remains valid during routine analysis.
The chapter will be published in Supplement 10.6 of the European Pharmacopoeia on 1 July 2021 with an implementation date of 1 January 2022.
- European Pharmacopoeia 10th Edition
- European Pharmacopoeia Commission
- European Pharmacopoeia work programme