Revision of USP <1085> "Guidelines on Endotoxin Test"

As recently reported, the USP has been working intensively on the chapters on the endotoxin test and has recently created the future Chapter <86> on recombinant tests, which should of course be seen in conjunction with Chapter <85> Bacterial Endotoxins and Chapter <1085> Guidelines on the Endotoxins Test. A revision proposal for the latter has now also been proposed by the Expert Committee for Microbiology.

Content

This proposed revision includes a series of changes and adaptations:

• A change of title from "Guidelines for Endotoxin Testing" to "Guidelines for Testing for Endotoxins".
• An alignment of terminology in the "Background" section to harmonize it while updating the Endotoxins section and then moving it to the Background section.
• Update the document to include recombinant reagents and revise the terminology to include both lysate and recombinant reagents.
• A reference to the general guidance for alternative tests will be included.
• Deletion of the glossary with reference to the definitions that can now be found in the Microbiology Glossary <1117.1>

It also integrates the provision of more information and clarification on the following topics:

• Preparatory requirements, including calibration of RSE to CSE
• Screening and qualification of laboratory equipment, devices and instruments used for BET
• Calculation of endotoxin limits for products, preparations, substances and medical devices
• Criteria for positive control products (PPC)
• Test interferences, including an updated Table 3 indicating whether they apply to all reagents or only to LAL reagents
• Routine testing, with further guidance on sampling of raw materials, finished products and pooling
• Calculation of endotoxin content and updated guidelines for OOS testing
• Update of standard graph control to include fluorescence testing and inclusion of information on the use of archived graphs

Further details on the changes can be found in the revision proposal on the USP website after registration.