Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals

Hardcover | July 18, 2003

bySatinder Ahuja, Karen Mills AlsanteEditorSatinder Ahuja

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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.

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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 t...

Dr. Satinder Ahuja is a leading expert on improving water quality. He earned his PhD in analytical chemistry from the University of the Sciences, Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years while simultaneously teaching and guiding research as an adjunct professor at Pace University for ...

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Format:HardcoverDimensions:430 pages, 7.44 × 9.69 × 0.98 inPublished:July 18, 2003Publisher:Academic PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:012044982X

ISBN - 13:9780120449828

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Table of Contents

OVERVIEW: ISOLATION AND CHARACTERIZATION OF IMPURITIES;
REVIEW OF REGULATORY GUIDANCE ON IMPURITIES; POLYMORPHIC & SOLVATOMORPHIC IMPURITIES; IMPURITIES IN DRUG PRODUCTS; STRATEGIES FOR INVESTIGATION AND CONTROL OF PROCESS AND DEGRADATION-RELATED IMPURITIES; REFERENCE STANDARDS; SAMPLE SELECTION FOR ANALYTICAL METHOD DEVELOPMENT; SAMPLE PREPARATION METHODS; ISOLATION METHODS I: THIN-LAYER CHROMATOGRAPHY; ISOLATION METHODS II: COLUMN CHROMATOGRAPHY; MASS SPECTRAL CHARACTERIZATION; NMR CHARACTERIZATION OF IMPURITES; HYPHENATED CHARACTERIZATION TECHNIQUES; SOLVING IMPURITY/DEGRADATION PROBLEMS: CASE STUDIES