Testing methods for bacterial endotoxins in borneol

doi:10.19803/j.1672-8629.20260121

Abstract

Abstract: Objective To establish the bacterial endotoxin limit and test method for the insoluble drug—borneol—and to validate the method. Methods The bacterial endotoxin limit for borneol was determined according to the Chinese Pharmacopoeia (2025 Edition). Borneol was dissolved in anhydrous ethanol and diluted with water for the bacterial endotoxin test (BET water). Interference and bacterial endotoxin recovery tests were performed using the gel method and kinetic turbidimetric assay. Results No interference was observed with either method when the sample dissolved in anhydrous ethanol was diluted at a dilution factor of 40 or more with BET water, and the results of each test met the related requirements. Conclusion The established method is applicable to testing of bacterial endotoxins in borneol, which can contribute to the improvement of quality standards for borneol as a traditional Chinese medicine. This study is expected to provide a reference for related tests.

Key words: Borneol, Bacterial Endotoxin, Gel Method, Kinetic Turbidimetric Assay, Anhydrous Ethanol, Insolubility, Interference Test

CLC Number:

R927.1

Chen Zhong, Yang Bin, Zhang Huang, Deng Xingui, Lin Yanqin, Fang Zhikai. Testing methods for bacterial endotoxins in borneol[J]. Chinese Journal of Pharmacovigilance, 2026, 23(9): 1011-1016.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20260121

https://zgywjj.magtechjournal.com/EN/Y2026/V23/I9/1011

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