The possibility of replacing the rabbit pyrogen test by the Limulus Amebocyte lysate (LAL) test, as a final release test for Large Volume Parenterals (LVPs) was investigated. The sensitivity and specificity of the LAL test and rabbit pyrogen assay were studied by means of artificially contaminated parenterals. Various LVPs (mostly containing electrolytes) were spiked with 0.5 and 5 EUlml o...

The observation that endotoxin caused gelation in extracts of Limulus amebocytes has been expanded to the development of an in vitro kinetic, quantitative chromogenic LAL assay (Kinetic-QCL) for the detection of endotoxin in aqueous fluids. Within the last 15 years, the use of Limulus amebocyte lysate to detect and control the presence of pyrogenic substances in pharmaceuticals and medical devi...

Based on the biological activity of endotoxin, we propose a possible new method for detecting endotoxin using a pH-indication system of macrophage culture media. After RAW 264.7 macrophage cells were treated with lipopolysaccharide (LPS), the addition of fluorescein to the LPS-treated media reproductively reduced its absorption and emission spectra (it was a dose-dependent reduction). The advan...

Dr. Joseph Chen first presented Low Endotoxin Recovery (LER) in April 2013.1 A masking effect of endotoxin was observed with a matrix containing a chelating agent and a detergent, and the endotoxin potency was not successfully recovered by dilution or magnesium replacement, the usual way to overcome the inhibition caused by chelation. The LER brought us some concerns relating to the suitability...

Low Endotoxin Recovery (LER) was first presented by Dr. Joseph Chen in April 2013.1 A masking effect of endotoxin was observed with a matrix containing a chelating agent and a detergent, and the endotoxin potency was not successfully recovered by dilution or magnesium replacement, the usual way to overcome the inhibition caused by chelation. The LER brought us some concerns relating to the suit...

This year celebrates the 30th anniversary of the licensing of Limulus amebocyte lysate (LAL) by the US Food and Drug Administration (FDA) as a test for the presence of endotoxin in biologicals, pharmaceutical drugs, and medical devices. LAL is currently recognized by several major pharmacopoeias and is used worldwide. That a suitable alternative for the detection of endotoxin has not supplanted...

the possibility of replacing the rabbit pyrogen test by the limulus amebocyte lysate (lal) test, as a final release test for large volume parenterals (lvps) was investigated. the sensitivity and specificity of the lal test and rabbit pyrogen assay were studied by means of artificially contaminated parenterals. various lvps (mostly containing electrolytes) were spiked with 0.5 and 5 eulml of e.c...

it seems that rapid destruction of gram negative bacteria by antibiotics contributes to the clinical deterioration of some patients with gram negative infections. antibiotics increase the concentration of lipopolysaccharide (lps) in blood and cerebrospinal fluids. released lps can activate blood cells to produce tumor necrosis factor-alpha (tnf-a) and other cytokines. tnf-a appears to be a majo...

Abstract In the pharmaceutical industry, microbiological quality of water is vital. This research investigated how combining peracetic acid (0.1% V/V) and UV light (>150 mJ/cm2) as wide-spectrum disinfectants affect microbial endotoxin levels in a system. Water samples were taken aseptically from 12 points across The pour plate technique membrane filtration used for counts. presence dist...