Impurities evaluation of pharmaceuticals
"Providing a clear definition of the subject, Impurities Evaluation of Pharmaceuticals introduces techniques for isolating and characterizing impurities ... presents guidelines to evaluate stability using kinetic studies ... shows how to develop stability-indicating methodologies ... details various methods that require minimal sample preparation ... gives regulatory perspectives on chiral impurities ... and more."--BOOK JACKET
iv, 293 pages : illustrations ; 24 cm
9780824798840, 0824798848
38270589
1. An Overview
2. Regulations and Requirements for Controlling Impurities
3. Isolation and Characterization
4. Analytical Methodology
5. Synthesis-Related Impurities
6. Pharmaceutical Formulation-Related Impurities
7. Kinetic Studies
8. Stability Studies
9. Applications