CHINESE JOURNAL OF DRUG EVALUATION >

2025 , Vol. 42 >Issue 6: 426 - 426-430

DOI: https://doi.org/10.2095-3593.2026.010001

Evaluation of Bacterial Endotoxin Test Method for Amphotericin B Liposomes for Injection

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  • Beijing Institute for Drug Control Beijing Center for Vaccine Control， Beijing 102206

Received date: 2025-06-26

  Revised date: 2025-09-28

  Accepted date: 2026-01-07

  Online published: 2026-01-07

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Abstract

Objective： To establish an accurate and reliable method for bacterial endotoxin testing of amphotericin B liposomes for injection， in order to solve the problem of finding an accurate and effective method for bacterial endotoxin testing of amphotericin B liposomes for injection in current quality standards， and to address the issue of false positive results in existing quality standards. Methods： Two manufacturers′ dynamic colorimetric horseshoe crab reagents were used for inspection and testing， and the results were compared. At the same time， the dynamic turbidity method and gel method are tried to be used for the test. Results： The dynamic colorimetric method was used to detect the endotoxin content in amphotericin B liposomes for injection. There was a significant difference in the results of the two horseshoe crab reagents， and false positives were prone to occur. The gel method or dynamic turbidimetric method are used for determination， and the experimental results meet the specified requirements. Conclusion： Amphotericin B liposomes for injection are colored preparations， and their color is similar to the endpoint color of the dynamic colorimetric method， which poses a risk of color interference. Therefore， in order to avoid color interference， the dynamic turbidimetric method or gel method is usually recommended for endotoxin test. If dynamic colorimetric method is used for detection， there may be differences in the test results of horseshoe crab reagents produced by different manufacturing enterprises， and the risk of false positives is high. False positive results are also prone to occur. In order to avoid this situation， it is recommended to select dynamic turbidity method or gel method. The test results showed that the dynamic turbidimetric method and gel method were more reliable and accurate than the dynamic color display method in the detection of bacterial endotoxin in amphotericin B liposomes for injection. The dynamic color rendering method is more reliable and provides accurate results.

Key words： ; font-size:medium; ">Amphotericin B liposomes for injection； Dynamic color rendering method； Dynamic turbidity method； Gel method； Colored preparations

Cite this article

XIAO Siting, CAO Chunran . Evaluation of Bacterial Endotoxin Test Method for Amphotericin B Liposomes for Injection[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2025 , 42(6) : 426 -426-430 . DOI: 10.2095-3593.2026.010001

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