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A Multi-Disciplinary Approach to Impurity Identification , Elucidation , and Characterization

Introduction 1 The Importance of Chemical Context for the Identification, Elucidation, and Characterization of Process Impurities and Degradation Products 3 Common Techniques and Specialized Tools for Impurity Characterization and Elucidation 4 Specialized Tools for Mass Spectrometry 5 Specialized Tools for NMR Spectroscopy 7 Specialized Tools for Optical Spectroscopy 10 Bringing it All Together—An Electronic Platform for Collaboration and Reporting 10 Conclusion 11