Yes. The ability to detect endotoxins can be affected by storage and handling. Firms should establish procedures for storing and handling (which includes product mixing) samples for bacterial endotoxins analysis using laboratory data that demonstrate the stability of assayable endotoxins content. Protocols should consider the source of
endotoxins used in the study, bearing in mind that purified bacterial endotoxins might react differently from native sources of endotoxins.
