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Impurity Profiling of a New Drug Entity   Neeraj Mishra,Ashish Baldi and Ravindra K. Rawal

Impurity Profiling of a New Drug Entity

80 страниц. 2014 год.
LAP Lambert Academic Publishing
Impurity profiling and drug degradation pathways are essentials features for regulatory acceptance of any new drug entity. Despite of technological advancements in pharmaceutical analysis, structural elucidation of drug molecules, impurities produced during formulation remains challenging tasks for researchers. Unique chemical behavior, complex properties and interactions of different functional groups involved in active pharmaceutical ingredients along with different chemical environments with excipients and storage condition further complicate the issues. Furthermore isolation and characterization of impurities with special references to toxic metabolites is essential for acceptance of new drug molecules by regulatory agencies. Recently discovered and patented nitrate esters of paracetamol having improved analgesic and anti-inflammatory activities then parent drug and less hepatotoxicity in overdose is selected as model drug entity. This book is an attempt to provide experimental...
 
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