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 insights into the
chemical, analytical and establishment of drug degradation pathways
in forced conditions in lucid manner for easy understanding to meet
future expectations of scientific fraternities.
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