Abstract
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Highlights
The aim of this work is the evaluation and introduction to common day use of Limulus amebocyte lysate (LAL) test gel-clot method for assay of bacterial endotoxins in examined product
The Limulus amebocyte lysate (LAL) test is an alternative method to the rabbit pyrogen test focussed on detection of pyrogenic substaces in sterile parenteral drugs
There are many advantages of LAL test over the rabbit pyrogen test, one of the most important aspects of LAL test is that LAL test is in accordance with the latest demand of the European Pharmacopoeia Commission for the replacement of the animal-based tests in favour of alternative methods where possible
Summary
The aim of this work is the evaluation and introduction to common day use of LAL test gel-clot method for assay of bacterial endotoxins (the most common pyrogens) in examined product. The replacement of the rabbit pyrogen test by the LAL test gel-clot method is possible when the endotoxin limit for the observed drug product is defined, the set maximal endotoxin concentration level in such material is acceptable and standardised test procedures and validation techniques are established. Endotoxins Endotoxins are high-molecular-weight complexes associated with the outer membrane of gram-negative bacteria (GNB). They are the most usual cause of the elevated body temperature, induced by contaminated drug products. Their pyrogenic activity is higher than that of other pyrogenic substances. Endotoxins are similar to lipopolysacharids, they are heat stable and can survive the sterilisation process
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