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Analytical Method Development and Validation
Authors: Michael Swartz and Ira Krull
Publisher: Marcel Dekker, Inc.
Copyright: 3rd printing, 2000
Price: $35.00 (US dollars)
ISBN: 0-8247-0115-1
Page Count: 96
Michael Swartz works for Waters Corporation in Milford, MA, while Ira Krull
works for Northwestern University in Boston, MA. This book provides a concise
guide to specific approaches to the successful development, optimization,
and validation of HPLC-based analytical methods and demonstrates how these
steps can be integrated into a formal process that reflects current United
States Pharmacopeia (USP) regulations and International Conference on Harmonization
(ICH) contributions. Contents include method development, optimization,
and validation approaches; method validation (USP/ICH); system suitability;
method validation protocol; method transfer and revalidation.
To order, or for more information, contact:
Marcel Dekker, Inc.
270 Madison Avenue, New York, NY 10016 USA
Telephone: +1 212-696-9000
Hutgasse 4, Postfach 812, CH-4001 Basel, Switzerland
Telephone: +41 061-260-63-00
Web: http://www.dekker.com
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