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
