Download Free Handbook of Isolation and Characterization of Impurities in Pharmaceuticals
Handbook of Isolation and Characterization of Impurities in Pharmaceuticals
By:Satinder Ahuja,Karen Mills Alsante
Published on 2003-06-26 by Elsevier

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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.
This Book was ranked at 31 by Google Books for keyword Pharmaceutical.
Book ID of Handbook of Isolation and Characterization of Impurities in Pharmaceuticals's Books is 2HfY3_NLI_0C, Book which was written bySatinder Ahuja,Karen Mills Alsantehave ETAG "v8pXX4PAVnA"
Book which was published by Elsevier since 2003-06-26 have ISBNs, ISBN 13 Code is 9780080507767 and ISBN 10 Code is 008050776X
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Book which have "430 Pages" is Printed at BOOK under CategoryMedical
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