Analytical Method Development and Validation: 1st Edition (Paperback) book cover

Analytical Method Development and Validation

1st Edition

Edited by Michael E. Swartz, Ira S. Krull

CRC Press

96 pages

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Paperback: 9780824701154
pub: 1997-05-16
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Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.


". . .a useful primer-type book covering validation of analytical methods. . . .recommended."


"Stop and read this. . .book to understand a formal way to develop or to improve and validate your methods. . .. In answer to any query posed to you about your methods development technique, you could hand your well-worn copy of this small book to the questioner. There should be no further questions."


Table of Contents

Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.

Subject Categories

BISAC Subject Codes/Headings:
SCIENCE / Chemistry / Analytic