[Kinetic turbidimetric limulus assay of bacterial endotoxin in the replacement solution of on-line hemodiafiltration]
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Updated: Aug 11, 2026
Detection of Endotoxin in Nano-formulations Using Limulus Amoebocyte Lysate (LAL) Assays
Published on: January 30, 2019
Hai-yan Lao1, Qiu-xiao Lin, Min Yang
1Department of Pharmacy, People's Hospital of Guangdong Province, Guangzhou 510080, China. laohaiyan1208@vip.sina.com
Objective:
To determine bacterial endotoxin in the replacement solution of on-line hemodiafiltration (on-line HDF) using kinetic turbidimetric limulus test.
Methods And Results:
Validation test was performed with the replacement solution of on-line HDF in which quantified standard endotoxin was added. The recovery rates of endotoxin from the replacement solution and its dilutions at 1/5, 1/10, and 1/20 were 58.17%, 106.7%, 99.00% and 98.79%, respectively, suggesting that the optimal dilution was at 1/10. Standard endotoxin was added into the replacement solution of on-line HDF of 3 batches (040408, 040511,040527), and the recovery rates in their dilution at 1/10 were 76.32%, 99.00% and 96.24%, respectively. The standard endotoxin in the working curve was 1.00, 0.125, and 0.0156 Eu/ml (endotoxin unit/ml), and the dilution at 1/10 of the replacement solution is effective to eliminate the interference in limulus test.
Conclusion:
Kinetic turbidimetric limulus test provide a means to detect endotoxin in the replacement solution of on-line HDF.
