Description du livre
Provides accurate and current information on drug degradation pathways
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 conditionsSummarizes critical stability data for formulation and analytical scientists working in drug development and manufacturingOffers valuable insights into drug metabolism and in vivo degradation linked to potential toxicitiesUses a systematic and organized approach, grouping drugs by therapeutic categories and structural similaritiesIncludes 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.