Publisher description for Handbook of isolation and characterization of impurities in pharmaceuticals / edited by Satinder Ahuja, Karen Mills Alsante.
Bibliographic record and links to related information available from the Library of Congress catalog
Information from electronic data provided by the publisher. May be incomplete or contain other coding.
The objective of this book is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. It meets the critical need for a text that provides detailed guidance as to how these activities are actually carried out in the pharmaceutical industry.
Impurity identification is critical in the pharmaceutical industry because the FDA and other regulatory bodies around the world require that impurities in drug substance and drug product at certain levels be isolated and characterized.
· Provides valuable information on isolation and characterization of impurities
· Provides extensive hands-on experiences and experiments in this area
· Describes various considerations involved in meeting regulatory requirements
Library of Congress subject headings for this publication: Drugs Purification Handbooks, manuals, etc, Drugs Separation Handbooks, manuals, etc, Pharmaceutical Preparations analysis Handbooks, Pharmaceutical Preparations analysis Laboratory Manuals, Drug Contamination prevention & control Handbooks, Drug Contamination prevention & control Laboratory Manuals, Pharmaceutical Preparations standards Handbooks, Pharmaceutical Preparations standards Laboratory Manuals, Technology, Pharmaceutical methods Handbooks, Technology, Pharmaceutical methods Laboratory Manuals