A new method for concentration analysis of bacterial endotoxins in perfluorocarbon

Dan-Dan CHEN , Xiao-Ming FENG , Chun-Ren WANG , Qing-Quan HUANG , Zhao-Peng YANG , Qing-Yuan MENG

Front. Mater. Sci. ›› 2014, Vol. 8 ›› Issue (4) : 399 -402.

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Front. Mater. Sci. ›› 2014, Vol. 8 ›› Issue (4) : 399 -402. DOI: 10.1007/s11706-014-0267-3
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A new method for concentration analysis of bacterial endotoxins in perfluorocarbon

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Abstract

This communication demonstrates the feasibility of the gel-clot method for the analysis of bacterial endotoxins in water extracts of perfluorocarbon which is a water insoluble liquid medical device. Perfluorocarbon (10 mL) was shaken with 10 mL water for 15 min at 2000 r/min and the endotoxin present was extracted to the aqueous phase without interference inhibition/enhancement of the product and the recovery of endotoxin added to perfluorocarbon was determined. A validation study confirmed that endotoxins presented in perfluorocarbon pass over into the aqueous phase at concentrations of 20, 10 and 5 EU/mL with recoveries from 86.8% to 96.8%. Therefore, the gel-clot test is suitable for detecting bacterial endotoxins in perfluorocarbon which is a water insoluble medical device.

Keywords

perfluorocarbon / bacterial endotoxin / endotoxin recovery

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Dan-Dan CHEN, Xiao-Ming FENG, Chun-Ren WANG, Qing-Quan HUANG, Zhao-Peng YANG, Qing-Yuan MENG. A new method for concentration analysis of bacterial endotoxins in perfluorocarbon. Front. Mater. Sci., 2014, 8(4): 399-402 DOI:10.1007/s11706-014-0267-3

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