MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03630nam a2200433Ia 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
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 |
|---|
| System 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 |
| Item number |
HAN 2005 |
| Edition number |
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 |
|---|
| Formatted 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 |
TOC |
| 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 |
| 590 ## - LOCAL NOTE (RLIN) |
|---|
| Local note |
Abdul Gani |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical Preparations |
| 9 (RLIN) |
8964 |
|
|---|
| Topical term or geographic name as entry element |
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 |
Dewey Decimal Classification |
| 953 ## - Fulltext in GSDL |
|---|
| Is Fulltext Available in GSDL? |
Not Avaialable |