TY  - BOOK
AU  - Satinder,Ahuja
AU  -  Alsante,Karen Mills
TI  - Handbook of isolation and characterization of impurities in pharmaceuticals
SN  - 012044982X
U1  - 615.1901 22
PY  - 2005///
CY  - New Delhi
PB  - Elsevier
KW  - Pharmaceutical Preparations
KW  - Drug Contamination
KW  - Drugs-Analysis ContaminationTechnology
KW  - Pharmacy
N1  - 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; TOC; Pharmacy
N2  - 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
UR  - http://www.worldcat.org/title/handbook-of-isolation-and-characterization-of-impurities-in-pharmaceuticals/oclc/162129555&referer=brief_results
UR  - http://lib.ewubd.edu/ebook/5746
ER  -