5 Batch Analysis

Studies follow the linear way listed below
  • Pre-screening of 5-batches for impurities including 3D screening
  • Impurity identification and structure elucidation in consultation with the sponsor
  • Isolation/synthesis of impurities required for 5-batch analysis
  • GLP analysis of 5-batches using validated analytical methods for active ingredient content and impurities
  • Characterization of 5 commercial batches along with reference standards by UV, IR, NMR, LC-MS/MS and/or GC-MS as applicable