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Handbook of isolation and characteri...

Ahuja, Satinder, (1933-)

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Handbook of isolation and characterization of impurities in pharmaceuticals

Record Type:	Electronic resources : Monograph/item
Title/Author:	Handbook of isolation and characterization of impurities in pharmaceuticals/ edited by Satinder Ahuja, Karen Mills Alsante.{me_controlnum}
other author:	Ahuja, Satinder,
Published:	Amsterdam ;Academic Press, : 2003.,
Description:	xvi, 414 p. :ill. ;27 cm.
[NT 15003449]:	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.
Subject:	Drugs - Handbooks, manuals, etc. - Purification -
Online resource:	http://www.sciencedirect.com/science/book/9780120449828An 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.{me_controlnum} - 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:

1364703
Drugs
--Purification--Handbooks, manuals, etc.Index Terms--Genre/Form:

542853
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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245 0 0 $a Handbook of isolation and characterization of impurities in pharmaceuticals $h [electronic resource] / $c edited by Satinder Ahuja, Karen Mills Alsante.{me_controlnum}
250 $a 1st ed.
260 $a Amsterdam ; $a Boston : $b Academic Press, $c 2003.
300 $a xvi, 414 p. : $b ill. ; $c 27 cm.
490 1 $a Separation science and technology ; $v v. 5
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.
533 $a Electronic reproduction. $b Amsterdam : $c Elsevier Science & Technology, $d 2007. $n Mode of access: World Wide Web. $n System requirements: Web browser. $n Title from title screen (viewed on July 25, 2007). $n Access may be restricted to users at subscribing institutions.
650 0 $a Drugs $x Purification $v Handbooks, manuals, etc. $3 1364703
650 0 $a Drugs $x Separation $v Handbooks, manuals, etc. $3 1364704
650 1 2 $a Pharmaceutical Preparations $x analysis $v Handbooks. $3 1364705
650 2 2 $a Drug Contamination $x prevention & control $v Handbooks. $3 1364706
650 2 2 $a Pharmaceutical Preparations $x standards $v Handbooks. $3 1364707
650 2 2 $a Technology, Pharmaceutical $x methods $v Handbooks. $3 1364708
650 6 $a M�edicaments $x Purification $v Guides, manuels, etc. $3 1364709
650 6 $a M�edicaments $x S�eparation $v Guides, manuels, etc. $3 1364710
655 4 $a Electronic books. $2 lcsh $3 542853
700 1 $a Ahuja, Satinder, $d 1933- $4 edt $3 1068463
700 1 $a Alsante, Karen Mills. $4 edt $3 1364702
710 2 $a ScienceDirect (Online service) $3 848416
776 1 $c Original $z 012044982X $z 9780120449828 $w (DLC) 2003040309 $w (OCoLC)51437837
830 0 $a Separation science and technology (San Diego, Calif.) ; $v v. 4. $3 1364701
856 4 0 $3 ScienceDirect $u http://www.sciencedirect.com/science/book/9780120449828 $z An electronic book accessible through the World Wide Web; click for information
994 $a C0 $b TEF