Department of Pharmaceutical Analysis

Research Activity

  • QbD based analytical and bioanalytical method development
  • PK studies and metabolite profiling
  • Reverse engineering of complex products and sameness strategy development for regulatory submission
  • LC-MS and NMR based impurity profiling of NCEs and approved drugs
  • Degradation profiling of drug substances and drug products
  • Pre-formulation assessment of drugs including polymorph characterization and drug- excipient compatibility studies
  • Stability analysis of drug substance, intermediates and products
  • Characterization of complex generics and biosimilars
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