Handbook of isolation and characterization of impurities in pharmaceuticals / (Record no. 5746)

000 -LEADER
fixed length control field 03630nam a2200433Ia 4500
001 - CONTROL NUMBER
EWU control number 5746
003 - CONTROL NUMBER IDENTIFIER
control field BD-DhEWU
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20190113155806.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 140519r20052003ii g b 001 0 eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 012044982X
International Standard Book Number 9788181479822
International Standard Book Number 9780120449828
International Standard Book Number 9780080507767
International Standard Book Number 8181479823
International Standard Book Number 008050776X
035 ## - SYSTEM CONTROL NUMBER
OCLC control number (OCoLC)162129555
040 ## - CATALOGING SOURCE
Original cataloging agency BD-DhEWU
Modifying agency BD-DhEWU
Language of cataloging eng
Transcribing agency BD-DhEWU
041 ## - LANGUAGE CODE
Language code of text/sound track or separate title eng
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.1901
Author mark and Year HAN 2005
DDC edition 22
245 10 - TITLE STATEMENT
Title Handbook of isolation and characterization of impurities in pharmaceuticals /
Statement of responsibility, etc edited by Ahuja Satinder, & Karen Mills Alsante
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc New Delhi :
Name of publisher, distributor, etc Elsevier,
Date of publication, distribution, etc c2005.
300 ## - PHYSICAL DESCRIPTION
Extent xvi, 414 p. :
Other physical details ill. ;
Dimensions 24cm.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes Bibliographical References and Index.
505 ## - FORMATTED CONTENTS NOTE
Contents note OVERVIEW: ISOLATION AND CHARACTERIZATION OF IMPURITIES; --<br/>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.
Title Table of contents
520 ## - SUMMARY, ETC.
Summary, etc 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.
526 ## - STUDY PROGRAM INFORMATION NOTE
Program name Pharmacy
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name Pharmaceutical Preparations
9 (RLIN) 8964
Topical term or geographic name Drug Contamination
9 (RLIN) 8965
653 #1 - INDEX TERM--UNCONTROLLED
Uncontrolled term Drugs-Analysis ContaminationTechnology
Uncontrolled term Pharmacy
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Satinder, Ahuja
9 (RLIN) 8966
Personal name Alsante, Karen Mills.
9 (RLIN) 23785
856 42 - ELECTRONIC LOCATION AND ACCESS
Materials Specified WorldCat details
Uniform Resource Identifier http://www.worldcat.org/title/handbook-of-isolation-and-characterization-of-impurities-in-pharmaceuticals/oclc/162129555&referer=brief_results
Materials Specified E-book Fulltext
Uniform Resource Identifier http://lib.ewubd.edu/ebook/5746
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Text
Source of classification or shelving scheme
953 ## - Fulltext in GSDL
Is Fulltext Available in GSDL? Not Avaialable
Holdings
Lost status Source of classification or shelving scheme Not for loan Collection code Permanent Location Current Location Shelving location Date of accession Source of acquisition Cost, normal purchase price Full call number Barcode Copy number Koha item type Date last seen
    Not For Loan Non-fiction EWU Library EWU Library Reserve Section 2008-01-09 Paragon Enterprises Ltd. 2950.00 615.1901 HAN 2005 21337 C-1 Text  
      Non-fiction EWU Library EWU Library Circulation Section 2008-01-22 Bangaldesh Photostat 554.00 615.1901 HAN 2005 21392 C-3 Text  
      Non-fiction EWU Library EWU Library Circulation Section 2008-01-22 Bangaldesh Photostat 554.00 615.1901 HAN 2005 21395 C-6 Text  
      Non-fiction EWU Library EWU Library Circulation Section 2008-01-22 Bangaldesh Photostat 554.00 615.1901 HAN 2005 21397 C-8 Text  
    Not For Loan Non-fiction EWU Library EWU Library Reserve Section 2008-01-22 Bangaldesh Photostat 554.00 615.1901 HAN 2005 21391 C-2 Text  
      Non-fiction EWU Library EWU Library Circulation Section 2008-01-22 Bangaldesh Photostat 554.00 615.1901 HAN 2005 21393 C-4 Text  
      Non-fiction EWU Library EWU Library Circulation Section 2008-01-22 Bangaldesh Photostat 554.00 615.1901 HAN 2005 21394 C-5 Text  
      Non-fiction EWU Library EWU Library Circulation Section 2008-01-22 Bangaldesh Photostat 554.00 615.1901 HAN 2005 21396 C-7 Text  
      Non-fiction EWU Library EWU Library Circulation Section 2008-01-22 Bangaldesh Photostat 554.00 615.1901 HAN 2005 21398 C-9 Text  
      Non-fiction EWU Library EWU Library Circulation Section 2008-01-22 Bangaldesh Photostat 554.00 615.1901 HAN 2005 21399 C-10 Text  
      Non-fiction EWU Library EWU Library E-book 2017-12-06     615.1901 HAN 2005     E-Book 2017-12-06

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