Type of Notice: General Announcement
Posting Date: 25-Apr-2025
USP <86> Bacterial Endotoxin Test Using Recombinant Reagents is now approved for early adoption as of November 2024 with an official date of May 1, 2025.
The methodology described in <86> includes recombinant reagents based on rFC and rCR. This chapter was introduced to facilitate the use of the recombinant reagents as alternatives to the animal derived LAL reagents. Included in the methods described in the chapter are method suitability requirements as well as the expectation that the non-product specific aspects of the method will be validated.
Currently this chapter is considered to be an alternative method by USP, because it is not yet “applicable” (i.e., compendially required) to any official article in the USP-NF, and will remain so until the chapter is included in a monograph, another General Chapter, or the USP General Notices. USP is seeking data from stakeholders to build upon the strong database that already exists through examples of applicability to multiple product or material types before the chapter is made applicable to any official article in the USP-NF. The USP General Chapters Microbiology Expert Committee (MEC) is inviting stakeholders to share their data and/or rationales for applications utilizing methods employing recombinant reagents. We are interested in all relevant data from small molecule products, biological products, pharmaceutical waters, and other matrices tested using recombinant reagents.
The security of any information and data provided that is designated as confidential will be handled and maintained in a confidential manner and will only be evaluated by onboarded participants in USP’s expert bodies and relevant USP staff.
Your data may be submitted to USP by contacting microbiology@usp.org.