Analytical Method Development and Validation

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.

List of contents

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

About the author

Michael E. Swartz, Ira S. Krull

Summary

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. This text also presents an overview of Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) regulatory guidelines.

Product details

• Assisted by: Ira S Krull (Editor), Ira S. Krull (Editor), Michael E Swartz (Editor), Michael E. Swartz (Editor), Swartz Michael E. (Editor)
• Publisher: Taylor and Francis
• Languages: English
• Product format: Paperback / Softback
• Released: 16.05.1997
• EAN: 9780824701154
• ISBN: 978-0-8247-0115-4
• No. of pages: 96
• Weight: 180 g
• Subjects: Natural sciences, medicine, IT, technology > Chemistry > General, dictionaries; Non-fiction book > Nature, technology > Natural science; SCIENCE / Chemistry / Analytic, Analytical Chemistry