Method Validation in Pharmaceutical Analysis

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Method Validationin Pharmaceutical AnalysisEdited byJ. Ermer and J. H. McB. MillerMethod Validation in Pharmaceutical Analysis . A Guide to Best Practice. Joachim Ermer, John H. McB. Miller (Eds.)Copyright 2005 WILEY-VCH Verlag GmbH & Co. KGaA, WeinheimISBN: 3-527-31255-2Related Titles from Wiley-VCH:M. S. LeeLC/MS Applications in Drug Development2002ISBN: 0-471-40520-5M. Stoeppler, W. R. Wolf, P. J. Jenks (Eds.)Reference Materials for Chemical AnalysisCertification, Availability, and Proper Usage2001ISBN: 3-527-30162-3J. M. Miller, J. B. Crowther (Eds.)Analytical Chemistry in a GMP EnvironmentA Practical Guide2000ISBN: 0-471-31431-5Method Validation in Pharmaceutical AnalysisA Guide to Best PracticeEdited byJoachim Ermer, John H. McB. MillerEdited byDr. Joachim Ermersanofi-aventisIndustriepark H chstBuild. G87565926 FrankfurtGermanyDr. John H. McB. MillerEuropean Directorate for the Qualityof Medicines (EDQM)16, Rue Auguste Himly67000 StrasbourgFrance&This book was carefully produced.

2.3 Accuracy 63 Joachim Ermer 2.3.1 Drug Substance 64 2.3.2 Drug Product 67 2.3.3 Impurities/Degradants and Water 71 2.3.4 Cleaning Validation Methods 74 2.3.5 Acceptance Criteria 77 2.3.6 Key Points 79 2.4 Linearity 80 Joachim Ermer

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