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TitleHandbook of isolation and characterization of impurities in pharmaceuticals [electronic resource] / edited by Satinder Ahuja, Karen Mills Alsante
Imprint Amsterdam ; Boston : Academic Press, 2003
Edition 1st ed
Connect tohttp://www.sciencedirect.com/science/publication?issn=01496395&volume=5
Descript xvi, 414 p. : ill. ; 27 cm

SUMMARY

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


CONTENT

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


Drugs -- Purification -- Handbooks manuals etc Drugs -- Separation -- Handbooks manuals etc Pharmaceutical Preparations -- analysis -- Handbooks Pharmaceutical Preparations -- analysis -- Laboratory Manuals Drug Contamination -- prevention & control -- Handbooks Drug Contamination -- prevention & control -- Laboratory Manuals Pharmaceutical Preparations -- standards -- Handbooks Pharmaceutical Preparations -- standards -- Laboratory Manuals Technology Pharmaceutical -- methods -- Handbooks Technology Pharmaceutical -- methods -- Laboratory Manuals Mโedicaments -- Purification -- Guides manuels etc Mโedicaments -- Sโeparation -- Guides manuels etc Electronic books.



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