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Handbook of isolation and characterization of impurities in pharmaceuticals

紀錄類型:	書目-電子資源 : 單行本
正題名/作者:	Handbook of isolation and characterization of impurities in pharmaceuticals/ edited by Satinder Ahuja, Karen Mills Alsante.
其他作者:	Ahuja, Satinder,
出版者:	Amsterdam ;Academic Press, : 2003.,
面頁冊數:	xvi, 414 p. :ill. ; : 27 cm.;
標題:	Drugs - Handbooks, manuals, etc. - Purification -
電子資源:	An electronic book accessible through the World Wide Web; click for information
ISBN:	9780120449828

Handbook of isolation and characterization of impurities in pharmaceuticals
Handbook of isolation and characterization of impurities in pharmaceuticals[electronic resource] /edited by Satinder Ahuja, Karen Mills Alsante. - 1st ed. - Amsterdam ;Academic Press,2003. - xvi, 414 p. :ill. ;27 cm. - Separation science and technology ;v. 5. - Separation science and technology (San Diego, Calif.) ;v. 4..

Includes bibliographical references and index.

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.

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.

Electronic reproduction.
Amsterdam :
Elsevier Science & Technology,
2007.

Mode of access: World Wide Web.

ISBN: 9780120449828

Source: 90743:90743Elsevier Science & Technologyhttp://www.sciencedirect.comSubjects--Topical Terms:

322244
Drugs
--Purification--Handbooks, manuals, etc.Index Terms--Genre/Form:

96803
Electronic books.

LC Class. No.: RS404.5 / .H355 2003eb

Dewey Class. No.: 615/.19

National Library of Medicine Call No.: 2004 D-216

Handbook of isolation and characterization of impurities in pharmaceuticals
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504 $a Includes bibliographical references and index.
505 0 $a 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.
520 $a 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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