Evaluation of limulus amebocyte lysate and recombinant endotoxin alternative assays for an assessment of endotoxin detection specificity

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endotoxin contamination of large volume parenterals as detected by limulus amebocyte lysate as an alternative to rabbit pyrogen test

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...

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ژورنال

عنوان ژورنال: European Journal of Pharmaceutical Sciences

سال: 2021

ISSN: 0928-0987

DOI: 10.1016/j.ejps.2021.105716