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General Chapter Prospectus: <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs)

Type of Posting: General Chapter Prospectus
Posting Date: 25-Sep-2020
Expert Committee: Botanical Dietary Supplements and Herbal Medicines (BDSHM)
Input Deadline: 30-Oct-2020

Proposed New Title: <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs)

Suggested audience: Suppliers of botanical ingredients, dietary supplement manufacturers producing botanical products and testing laboratories. 

Estimated Proposal PF: 47(3) [May-Jun. 2021]

Background and objective(s): Pyrrolizidine Alkaloids (PAs) are esters of alkaloids consisting of a necine base moiety, esterified with a necic acid. Currently, more than 660 PAs and their respective N-oxides are known to be hepatotoxic, carcinogenic and genotoxic; they have been identified in over 6,000 plant species. The worldwide presence of these plants may lead to contamination of food, food supplements, herbal medicines, and animal feed. It is envisioned that a prototype analytical method and specifications will be described in the general chapter. 

Description of scope and application: The scope of this general chapter covers trace analysis of target PAs occurring in botanical ingredients and products due to contamination from other plants. 

Preliminary outline: 

  • Introduction
  • Principle
  • Limits
  • Sample Preparation
  • Procedure
  • Validation Requirement

Anticipated activities: USP is requesting early input from stakeholders on this newly proposed General Chapter <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs) which is planned to be published for comment in Pharmacopeial Forum

Contact: Sandeep Putty, Associate Scientific Liaison (301-692-3664,