Pyrrolizidine Alkaloids: USP Proposal for Contaminant Analysis

In addition to the new USP Chapter <1567> Pyrrolizidine Alkaloids recently announced, the USP is proposing a new chapter entitled <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs). The deadline for comments is 30 October 2020. While the USP chapters with numbers above 1000 are provided for information, the USP chapter numbers below 1000 are considered to be mandatory.

Beforehand, the EDQM had already announced the elaboration of a new Ph. Eur. Chapter 2.8.26. Contaminant pyrrolizidine alkaloids. EMA's HMPC has also published an update of the 2014 public statement with newly recommended PA limit values.

The scope of the new USP chapter <567> covers the trace analysis of PAs that may be present in herbal source materials and products due to contamination with other (PA containing) plants. However, according to the HMPC, contamination of herbal source materials with PA-containing weeds should not occur at all due to the pharmaceutical product quality requirements and compliance with GACP and GMP.

Preliminary overview of <567>

The chapter will contain an analytical method including specifications. According to the USP, the following sections are provided in chapter <567>:

• Introduction
• Principle
• Limits
• Sample Preparation
• Analytical Procedure
• Validation requirements

The USP draft chapter is expected to be published for comments in Pharmacopeial Forum 47(3) [May-June 2021]. Further information can be found on the USP's Compendial Notices website "General Chapter Prospectus: <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs)".