7/8 October 2021
A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids has been proposed for comment in the recent issue of Pharmeuropa (32.1). The deadline for comments is 31 March 2020.
Pyrrolizidine alkaloids (PAs) are nitrogen-containing compounds that occur naturally in plants. According to the draft chapter, there are several hundred structurally distinct PAs in several thousand different plant species. Many of these plants are common weeds, which can contaminate raw plant materials used for the production of herbal medicinal products (HMPs). This can result in contamination of raw plant materials by PAs, usually at very low levels. Therefore, this new general chapter covers trace analysis of target PAs in herbal drugs, herbal drug preparations and HMPs. The chapter proposes a list of 28 different PAs as target PAs.
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 (1.0 µg or 0.35 µg according to EMA/HMPC/328782/2016, subject to revision of these values).
A liquid chromatography procedure coupled with mass spectrometry (LC-MS) is proposed as an example method. It describes an analytical procedure that has been shown to be suitable for the determination of target PAs in a number of matrices. However, the use of any procedure consisting of chromatography coupled with MS/MS or high resolution MS that meets the validation requirements specified in the chapter is permitted. Once an analytical procedure has been shown to meet the validation requirements for a representative matrix (e.g. dried peppermint leaf) the procedure is assumed to be valid for any other matrix belonging to the corresponding matrix group (e.g. leaf). However, the validity of an individual method should be confirmed through successful participation in proficiency tests on a regular basis.
Following your registration to Pharmeuropa online you will have access to the full Ph. Eur. draft for 2.8.26. Contaminant pyrrolizidine alkaloids.