by Satinder Ahuja

Filling a gap in the pharmaceutical literature, this unique guide addresses the development of targeted methodologies to monitor impurities in pharmaceutical compounds and drug products. Furnishes physicochemical protocols to determine the purity of pharmaceutical compounds fully before pharmacological and toxicological studies begin!

Providing a clear definition of the subject, Impurities Evaluation of Pharmaceuticals:

• introduces various 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 prepreparation
• gives regulatory perspectives on chiral impurities
• and more!

Containing important literature citations and offering an invaluable list of applications, Impurities Evaluation of Pharmaceuticals is an outstanding resource for pharmacists and pharmacologists, clinical microbiologists, quality assurance and production managers in the pharmaceutical industry, analytical chemists and biochemists, pharmaceutical regulatory personnel, and upper-level undergraduate, graduate, and continuing-education students in these disciplines.

Contents

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

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