Understanding the degradation chemistry of pharmaceuticals is essential for drug formulation, stability testing, and regulatory compliance. Compendium of Drug Degradation Pathways presents a detailed analysis of the degradation pathways of approximately 350 widely used prescription and over-the-counter drugs, making it an indispensable reference for formulation and analytical scientists.

Drug stability and impurity characterization play a critical role in pharmaceutical research and development, as degradation can impact efficacy, safety, and regulatory approval. Structured alphabetically, this compendium organizes degradation data into concise monographs, each summarizing a drug’s chemical structure, degradation pathways, and stability considerations. By collating information from regulatory guidelines, scientific literature, and real-world drug formulations, Dr. Min Li provides formulation chemists, regulatory scientists, and medicinal chemists with a clear understanding of degradation mechanisms under practical storage conditions.

• Provides guidance on real-world drug degradation under long-term stability conditions
• Summarizes critical stability data for formulation and analytical scientists working in drug development and manufacturing
• Offers valuable insights into drug metabolism and in vivo degradation linked to potential toxicities
• Uses a systematic and organized approach, grouping drugs by therapeutic categories and structural similarities
• Includes a dedicated introduction on regulatory perspectives, impurity characterization, and stress testing methodologies

With increasing regulatory scrutiny on drug quality and safety, Compendium of Drug Degradation Pathways is a critical reference for professionals in pharmaceutical sciences, intellectual property law, and regulatory agencies reviewing Chemistry, Manufacturing, and Controls (CMC) sections of NDAs and ANDAs.