000			03630nam a2200433Ia 4500
001			5746
003			BD-DhEWU
005			20190113155806.0
008			140519r20052003ii g b 001 0 eng d
020			_a012044982X
020			_a9788181479822
020			_a9780120449828
020			_a 9780080507767
020			_a8181479823
020			_a008050776X
035			_a(OCoLC)162129555
040			_aBD-DhEWU _dBD-DhEWU _beng _cBD-DhEWU
041			_aeng
082	0	4	_a615.1901 _bHAN 2005 _222
245	1	0	_aHandbook of isolation and characterization of impurities in pharmaceuticals / _cedited by Ahuja Satinder, & Karen Mills Alsante
260			_aNew Delhi : _bElsevier, _cc2005.
300			_axvi, 414 p. : _bill. ; _c24cm.
504			_aIncludes Bibliographical References and Index.
505			_aOVERVIEW: 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. _tTOC
520			_aThe 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			_aPharmacy
590			_aAbdul Gani
650			_aPharmaceutical Preparations _98964
650			_aDrug Contamination _98965
653		1	_aDrugs-Analysis ContaminationTechnology
653		1	_aPharmacy
700	1		_aSatinder, Ahuja _98966
700	1		_a Alsante, Karen Mills. _923785
856	4	2	_3WorldCat details _uhttp://www.worldcat.org/title/handbook-of-isolation-and-characterization-of-impurities-in-pharmaceuticals/oclc/162129555&referer=brief_results
856	4	2	_3E-book Fulltext _uhttp://lib.ewubd.edu/ebook/5746
942			_cTEXT _2ddc
953			_a0
999			_c5746 _d5746
999			_c5746 _d5746