| Popis: |
The synthesis, identification, and testing of drug metabolites are key in meeting regulatory guidelines. This chapter provides an overview of the methods available for generating metabolites through various means, using both chemical and biological approaches. Case studies are presented to illustrate the opportunities and challenges in producing metabolites by each method. We also address considerations needed in the purification and structure elucidation of metabolites using NMR spectroscopy, especially relevant now that the increased sensitivity of modern NMR instrumentation makes the definitive identification of metabolites possible with only low microgram quantities of purified metabolite material. |
