Method Validation in Pharmaceutical Analysis
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.
5.2.3 Variation of Example 1: More than on Strength of Drug Product 250 5.2.4 Example 2: Degradation Products from a Drug Product by HPLC During Early Drug Product Development: Proposal for a Validation Scheme 251 5.2.5 Example 3: Residual Solvents of a Drug Product by GC During Early Drug
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