The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter 5.1.10. Guidelines for using the test for bacterial endotoxins, published in this quarter’s issue of Pharmeuropa 38.2 for comment.

General chapter 5.1.10 provides guidance for the use of the test for bacterial endotoxins described in general chapter 2.6.14. Bacterial endotoxins. It has been revised to add the method using recombinant factor C (rFC) and to clarify which specific provisions apply only when using amoebocyte lysate. In addition, section 11 – ‘Replacement of a method prescribed in a monograph’ – has been reinstated and now includes a new reference to the method using recombinant cascade reagents (rCRs), which may be considered as an alternative method in accordance with the General Notices. The methods using rFC and rCRs avoid the use of animal-derived reagents. Revised general chapter 5.1.10 also reflects the changes introduced in general chapter 2.6.14, which will be published in Issue 13.1 of the Ph. Eur.

The draft general chapter has now been published in Pharmeuropa 38.2, where it will remain open for public consultation until the end of June 2026. All interested parties are encouraged to review it and submit their comments.

For more information on how to comment, please consult our “How to comment” guide. Comments from states parties to the European Pharmacopoeia Convention should be sent to the responsible national pharmacopoeia authority (NPA); comments from other countries or from industry associations should be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.

Access the draft general chapter in Pharmeuropa 38.2

Deadline for comments: 30 June 2026

More information on how to comment can be found here: Comment on drafts (Pharmeuropa).