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

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.