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Identification and determination of impurities in drugs

Record Type:	Electronic resources : Monograph/item
Title/Author:	Identification and determination of impurities in drugs/ edited by S�andor G�or�og.
other author:	G�or�og, S.
Published:	Amsterdam ;Elsevier, : 2000.,
Description:	xxiii, 748 p. :ill. ; : 23 cm.;
Subject:	Drugs - Analysis. -
Online resource:	http://www.sciencedirect.com/science/book/9780444828996
ISBN:	9780444828996

Identification and determination of impurities in drugs
Identification and determination of impurities in drugs[electronic resource] /edited by S�andor G�or�og. - 1st ed. - Amsterdam ;Elsevier,2000. - xxiii, 748 p. :ill. ;23 cm. - Progress in pharmaceutical and biomedical analysis ;v. 4. - Progress in pharmaceutical and biomedical analysis ;v. 5..

Includes bibliographical references and index.

Chapter headings: Various Aspects of the Estimation of Impurities in Drugs. Identification, Structure Elucidation and Determination of Related Organic Impurities. Identification and Determination of Residual Solvents. Identification, Semiquantitative and Quantitative Determination of Inorganic Impurities. Degradation Products as Impurities. Determination of Enantiomeric Impurities. Estimation of Polymorphic Modifications as Impurities in Drugs. Microbiological Examination of Non-Sterile Drugs and Raw Materials. Selected Examples (Impurity Profiling of Some Groups of Drugs).

Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Since this is the best way to characterise the quality and stability of bulk drugs and pharmaceutical formulations, this is the core activity in modern drug analysis. Due to the very rapid development of the analytical methodologies available for this purpose and the similarly rapid increase of the demands as regards the purity of drugs it is an important task to give a summary of the problems and the various possibilities offered by modern analytical chemistry for their solution. That is the aim of this book. The book is methodology-oriented. In the first chapter some important aspects of the background of impurity-related analytical studies (toxicological, pharmacopoeial aspects, the characterisation of the sources of impurities and the role of impurity profiling in various fields of drug research, production and therapeutic use) are summarised. Chapter two deals with related organic impurities, the strategies for impurity profiling, the use of chromatographic and related separation methods, spectroscopic, and hyphenated techniques. The subject of the third chapter is the identification and determination of residual solvents. The determination of inorganic impurities is discussed in chapter four. The special problems of degradation products as impurities are dealt with in chapter five. A separate chapter has been compiled to deal with one of the most up-to-date problems in contemporary pharmaceutical analysis, the estimation of enantiomeric purity of chiral drugs. Chapter seven is devoted to various approaches to solve the problem of polymorphic modifications as impurities. Since in the broader sense of the word the microbiological purity of drugs and drug products also belongs to this circle, the most important information from this field is summarised in chapter eight. After the mainly methodology-oriented chapters, the final one concentrates on four groups of drugs (peptides, biotechnological products, antibiotics and steroids) in order to demonstrate the use of the methods described earlier.

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

Mode of access: World Wide Web.

ISBN: 9780444828996

Source: 122768:127765Elsevier Science & Technologyhttp://www.sciencedirect.comSubjects--Topical Terms:

123957
Drugs
--Analysis.Index Terms--Genre/Form:

96803
Electronic books.

LC Class. No.: RS189 / .I29 2000eb

Dewey Class. No.: 615/.1901

National Library of Medicine Call No.: W1 / PR677LM v.4 2000

Identification and determination of impurities in drugs
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505 0 $a Chapter headings: Various Aspects of the Estimation of Impurities in Drugs. Identification, Structure Elucidation and Determination of Related Organic Impurities. Identification and Determination of Residual Solvents. Identification, Semiquantitative and Quantitative Determination of Inorganic Impurities. Degradation Products as Impurities. Determination of Enantiomeric Impurities. Estimation of Polymorphic Modifications as Impurities in Drugs. Microbiological Examination of Non-Sterile Drugs and Raw Materials. Selected Examples (Impurity Profiling of Some Groups of Drugs).
520 $a Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Since this is the best way to characterise the quality and stability of bulk drugs and pharmaceutical formulations, this is the core activity in modern drug analysis. Due to the very rapid development of the analytical methodologies available for this purpose and the similarly rapid increase of the demands as regards the purity of drugs it is an important task to give a summary of the problems and the various possibilities offered by modern analytical chemistry for their solution. That is the aim of this book. The book is methodology-oriented. In the first chapter some important aspects of the background of impurity-related analytical studies (toxicological, pharmacopoeial aspects, the characterisation of the sources of impurities and the role of impurity profiling in various fields of drug research, production and therapeutic use) are summarised. Chapter two deals with related organic impurities, the strategies for impurity profiling, the use of chromatographic and related separation methods, spectroscopic, and hyphenated techniques. The subject of the third chapter is the identification and determination of residual solvents. The determination of inorganic impurities is discussed in chapter four. The special problems of degradation products as impurities are dealt with in chapter five. A separate chapter has been compiled to deal with one of the most up-to-date problems in contemporary pharmaceutical analysis, the estimation of enantiomeric purity of chiral drugs. Chapter seven is devoted to various approaches to solve the problem of polymorphic modifications as impurities. Since in the broader sense of the word the microbiological purity of drugs and drug products also belongs to this circle, the most important information from this field is summarised in chapter eight. After the mainly methodology-oriented chapters, the final one concentrates on four groups of drugs (peptides, biotechnological products, antibiotics and steroids) in order to demonstrate the use of the methods described earlier.
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.
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