Methods of potency determination and labeling of endotoxin refenrence standard

Objective:To introduce the methods for potency determination and labeling of control standard endotox- in(CSE).Method:Introduce the method for potency determination of CSE and requirements adopted by US FDA and the current two methods for potency labeling of CSE-fixed potency labeling and floating potency labeling meth- od.Analyze the advantages and disadvantages of these two labeling methods for CSE potency.Results:Provided fixed CSE potency labeling method is adopted,the impact of RSE/CSE ratio difference is ignored,which will affect the preciseness and reliability of bacterial endotoxin test(BET).Conclusion:Floating CSE potency labeling method should be adopted.