E5027
Sigma

Endotoxins: Pyrogens, LAL Testing, and Depyrogenation, 2nd ed.

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General description

This revised edition focuses on environmental prevalence, detection, properties, and biological structure and function of endotoxins from a parenteral manufacturing perspective, including in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate (LAL), such as assay development, automation, and depyrogenation. It surveys shift in emphasis away from pyrogens to endotoxins and development and proliferation of semiautomated kinetic LAL assays. With regulatory references and analytical protocols, this book emphasizes application of contamination control in pharmaceutical industry and details instances of endotoxin parenteral contamination.

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Identifiers

ISBN-10

0-8247-9362-5

ISBN-13

978-0-8247-9362-3

Properties

publication info

K. Williams, Marcel Dekker, 2001, 384 pp., hard cover

Table of Contents

Historical Foundations of Pyrogen Research
Pyrogen, Endotoxin, and Fever: An Overview
Endotoxin Structure, Function, and Activity
The Host Response to Endotoxin
Nonendotoxin Microbial Pyrogens: Lesser Endotoxins, Superantigens, and Adventitious Agents
Nonmicrobial Exogenous Pyrogens and Drug Fever
Pharmaceutical Manufacturing Contamination Control
Endotoxin as a Standard
The Rabbit Pyrogen Test
LAL Discovery, Mechanism, and Application
LAL Assay Development, Validation, and Regulation
Automation and Viewing Kinetic Data
Prospective Tests for Endotoxin and Other Microbial Artifacts
Depyrogenation Validation, Pyroburden, and Endotoxin Removal from Drugs
Therapeutic Approaches to Gram-Negative Sepsis

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