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Ph. Eur. seeks feedback on new general chapter on pyrrolizidine alkaloids

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European Pharmacopoeia
General text/chapter
News
19 December 2019
Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 2.8.26 on contaminant pyrrolizidine alkaloids. Users and concerned parties can submit their comments in Pharmeuropa 32.1 until 31 March 2020.

Pyrrolizidine alkaloids are nitrogen-containing compounds that occur naturally in plants. Hundreds of structurally distinct PAs have been found in thousands of different plant species. Many of these plants are common weeds which can contaminate, usually at very low levels, the raw plant material used for the production of herbal medicinal products (HMPs). The scope of this new general chapter is trace analysis of target pyrrolizidine alkaloids in herbal drugs, herbal drug preparations and HMPs contaminated with other plants, rather than the determination of pyrrolizidine alkaloids occurring naturally in plants.

This is the first general chapter specifically covering contaminant pyrrolizidine alkaloids. Their acute toxicity, genotoxicity and carcinogenic potential have been known for decades. Patient exposure to pyrrolizidine alkaloids from HMPs should be as low as possible and must not exceed the maximum daily intakes agreed by competent authorities.

This general chapter, which describes 28 target pyrrolizidine alkaloids, allows for 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 itself. 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 pyrrolizidine alkaloids.

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 pyrrolizidine alkaloids 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.

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