There has been considerable discussion in the literature recently pertaining to the Bacterial Endotoxins Test, its significance and interpretation, and its comparison to the USP rabbit test. The topic was previously briefly addressed via Inspection Technical Guide No. Additionally, the agency has approved the use of the Bacterial Endotoxins Test for many drug and device products. Also sources and methods of depyrogenation will be discussed. The limitations of the rabbit pyrogen test should be recognized when reviewing systems during inspections of sterile drug and device manufacturers.
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Would you like to tell us about a lower price? If you are a seller for this product, would you like to suggest updates through seller support? This source expertly examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective, with in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate LAL such as assay development, automation, depyrogenation.
Completely revised and expanded, this Third Edition contains the knowledge necessary to apply endotoxin testing in the increasingly complex pharmaceutical environment, featuring sections detailing the latest information regarding clinical advances, regulation standards, and validation procedures for computerized kinetic tests.
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ISBN 13: 9780824793623
U.S. Food and Drug Administration