E5027
Sigma
Endotoxins: Pyrogens, LAL Testing, and Depyrogenation, 2nd ed.
| ISBN-10: | 0-8247-9362-5 |
| ISBN-13: | 978-0-8247-9362-3 |
Description
| 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. |
Properties
| publication info | K. Williams, Marcel Dekker, 2001, 384 pp., hard cover |
Table Of Contents
| 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 |
