Compendium of Drug Degradation Pathways

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Free Download Compendium of Drug Degradation Pathways
by Min Li
English | 2025 | ISBN: 1118832930 | 636 pages | True PDF | 25.53 MB

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 Pathwayspresents 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 Lin 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 andin vivodegradation 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 Pathwaysis 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.



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