Endotoxine und Pyrogene: Nachweisverfahren, Produktprufung, Inaktivierung

This book provides a comprehensive overview of available and adopted methods for detecting bacterial endotoxins and other pyrogens in the European pharmaceutical industry. It includes detailed descriptions of each method, with practical examples and product-related validation. Recent findings on endotoxin masking and low endotoxin recovery are discussed, along with advanced methods using recombinant test systems. Necessary equipment and primary application areas are also covered.

Format: Hardback
Length: 208 pages
Publication date: 09 June 2021
Publisher: Wiley-VCH Verlag GmbH

This first German-language overview covers practically all available and accepted methods for detecting bacterial endotoxins and other pyrogens in the European Pharmacopoeia. Each method is thoroughly described, with practical examples including product-related method validation. The latest findings on endotoxin masking and the low endotoxin recovery (LER) effect, as well as new methods for endotoxin detection using recombinant test systems, are presented. The book also provides a description of the necessary equipment and the main application areas.

Introduction:
This first German-language overview covers practically all available and accepted methods for detecting bacterial endotoxins and other pyrogens in the European Pharmacopoeia. Each method is thoroughly described, with practical examples including product-related method validation. The latest findings on endotoxin masking and the low endotoxin recovery (LER) effect, as well as new methods for endotoxin detection using recombinant test systems, are presented. The book also provides a description of the necessary equipment and the main application areas.

Methodology:
The methods covered in this overview include both traditional and modern techniques, such as chromatography, immunoassays, and molecular methods. Each method is described in detail, including its principles, reagents, and procedures. Practical examples are provided to illustrate the application of the methods in different industries.

Validation:
Validation is an essential aspect of any method used for endotoxin detection. The methods described in this overview are validated according to international guidelines and standards, such as the European Pharmacopoeia and the United States Pharmacopeia. Validation includes the evaluation of specificity, sensitivity, linearity, and reproducibility.

Application:
Endotoxins are commonly found in various products, including pharmaceutical preparations, medical devices, and foodstuffs. The methods described in this overview are used in different industries, such as pharmaceutical manufacturing, food industry, and medical device industry. Practical examples are provided to illustrate the application of the methods in real-world scenarios.

Conclusion:
This first German-language overview provides a comprehensive and up-to-date coverage of available methods for detecting bacterial endotoxins and other pyrogens in the European Pharmacopoeia. The methods described are validated and widely used in different industries. By understanding and applying these methods, organizations can ensure the safety and quality of their products.

Weight: 560g
Dimension: 246 x 177 x 15 (mm)
ISBN-13: 9783527346950