Abstract
The Limulus Amebocyte Lystae (LAL) assay has realized numerous and varied applications including pyrogen testing of a number of pharmaceutical products. The time required to manually perform large numbers of LAL tests, and the subjectivity of gelation endpoints have been valid criticisms of the test. This report describes development of a rapid, automated instrument method for performance of LAL tests. The instrument automatically determined sequential changes in the optical density (O.D.) of up to 88 LAL reactions per analysis module at 1- or 5-min increments during a 1-hr assay period. Graphic representation of O.D. changes which occurred during the LAL-endotoxin reaction would be viewed on a cathode-ray tube or reproduced using a hard-copy printer. LAL preparations from six different commercial producers having similar endotoxin sensitivities by conventional gelation testing varied somewhat in suitability for automated turbidimetric measurements. Use of the instrument increased the sensitivity of certain of the LAL preparations by as much as 250-fold, with concentrations of endotoxin as low as 1 pg/ml being detectable. Several methods for calculation of the endotoxin content of test fluids were developed based upon the kinetics of the reaction between LAL and endotoxin. Adaptation of the instrument for LAL testing provides a rapid, objective automated method for pyrogen testing of a variety of pharmaceutical products.
- Received August 21, 1981.
- Accepted February 27, 1982.
- Copyright © Parenteral Drug Association. All rights reserved.
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