Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals
Download Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages.
Handbook of Isolation and Characterization of Impurities in Pharmaceuticals
The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.
Handbook of Isolation and Characterization of Impurities in Pharmaceuticals
The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.- Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.
Handbook of Trace Analysis
This handbook is unique in its comprehensive coverage of the subject and focus on practical applications in diverse fields. It includes methods for sample preparation, the role of certified reference materials, calibration methods and statistical evaluation of the results. Problems concerning inorganic and bioinorganic speciation analysis, as well as special aspects such as trace analysis of noble metals, radionuclides and volatile organic compounds are also discussed. A significant part of the content presents applications of methods and procedures in medicine (metabolomics and therapeutic drug monitoring); pharmacy (the analysis of contaminants in drugs); studies of environmental samples; food samples and forensic analytics – essential examples that will also facilitate problem solving in related areas.