Comparison and interpretation of guidelines for the application of bacterial endotoxin tests in Chinese and American Pharmacopoeia

doi:10.19803/j.1672-8629.20211190

Abstract

Abstract: Objective To provide reference for the detection, research and pharmacovigilance related to bacterial endotoxin in China. Methods USP 1085 and Chinese Pharmacopoeia 9251 were studied, and the similarities and differences in endotoxin reference material management, quality management and sections prone to misinterpretation in the guidelines were introduced and interpreted. Results USP 1085 and Chinese Pharmacopoeia 9251 were included in 2020 for the first time. Practitioners were given detailed guidance and descriptions on the background, testing, working standard calibration, quality management, limit calculation, and alternative methods. Conclusion USP 1085 and Chinese Pharmacopoeia 9251, as an authoritative guideline for bacterial endotoxin detection, is quite helpful for personnel engaged in endotoxin testing and for revision of Chinese Pharmacopoeia. It will be constantly revised and improved in the process of practice.

Key words: bacterial endotoxin detection, Chinese Pharmacopoeia, United States Pharmacopoeia, interpretation

CLC Number:

R926

PEI Yusheng, CHEN Chen, CAI Tong, ZHAO Xiaoyan, GAO Hua. Comparison and interpretation of guidelines for the application of bacterial endotoxin tests in Chinese and American Pharmacopoeia[J]. Chinese Journal of Pharmacovigilance, 2023, 20(3): 317-320.

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