Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs.

Table of Contents

• About the Editor
• List of Contributors
• Preface
• Acknowledgment
• Chapter 1: Drug Approval Process and Regulatory Requirements
• Chapter 2: Pharmacopeias and Compendial Approval Process
• Chapter 3: Common Methods in Pharmaceutical Analysis
• Chapter 4: Common Calculations
• Chapter 5: Analytical Method Validation, Verification, and Transfer
• Chapter 6: Specifications
• Chapter 7: Impurities
• Chapter 8: Good Documentation Practices
• Chapter 9: The Management of Analytical Laboratories
• Chapter 10: Analytical Instrument Qualification
• List of Abbreviations