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Nanomedicine (Lond). 2019 May;14(10):1231-1246. doi: 10.2217/nnm-2018-0339.

Sensitive method for endotoxin determination in nanomedicinal product samples.

Author information

1
Centre for Health Protection, National Institute for Public Health & the Environment (RIVM), Bilthoven, The Netherlands.
2
Department of Toxicogenomics, Maastricht University, Maastricht, The Netherlands.
3
Finnish Institute of Occupational Health, Helsinki, Finland.
4
Utrecht University, Utrecht, The Netherlands.
5
University of Zaragoza, Zaragoza, Spain.

Abstract

Aim: Nanomaterials and nanomedicinal products tend to interfere with various commonly used assays, including regulatory required endotoxin detection methods for medicines. We developed a method to quantify endotoxin levels that is compatible with nanomaterials and nanomedicinal products. Materials & methods: The method is based on measuring endotoxin indirectly via 3-hydroxylated fatty acids of lipid-A, using Ultra High Performance Liquid Chromatography coupled with mass spectrometry. The outcome was related to results of the commonly used Limulus Amebocyte Lysate method. Results: The ultra high performance liquid chromatography coupled with mass spectrometry method has clear advantages compared with other endotoxin determination assays; particularly the absence of nanospecific interference. Conclusion: The method is sensitive, straightforward and accurate in determining and quantifying endotoxin in nanomedicinal product samples.

KEYWORDS:

LAL assay; fatty acids; interference; lipopolysaccharide; nanomaterials; nanomedicine

PMID:
31124759
DOI:
10.2217/nnm-2018-0339

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