Abstract: Objective To establish a specific national standard for bacterial endotoxins for 9301 monocyte activation reaction tests specified in the Chinese Pharmacopoeia, and to ensure the quality and safety of injections. Methods The first batch of national standards for bacterial endotoxins (for monocyte activation reaction tests) was established through production preparation, collaborative calibration, uniformity inspection and other studies. Results Five institutes of drug control were invited to use three methods for collaborative calibration. The calibration results showed no significant difference as evidenced by analysis of variance. The weighted average of the candidate products was 152.0 EU per vial, with a 95% confidence interval of 136.2~169.5.0 EU per vial, and the confidence limit rate was 10.96%. The result of uniformity study met the requirements. The average value of the test result of the candidate using the monocyte activation reaction test method was 144.6 EU per vial. Finally, the candidate was determined to be the national standard for bacterial endotoxin (for monocyte activation reaction tests), and the potency was 150 EU per vial. Conclusion The first batch of national standard for bacterial endotoxin (for monocyte activation reaction tests) has been established (batch number: 150608-202101).

Key words: bacterial endotoxins, standard products, tachypleus amebocyte lysate/limulus amebocyte lysate, monocyte activation test, collaborative calibration, safety