HPLC-UV/PDA/ELSD/Chiral methods for in-process materials, intermediates, NCE APIs, and oligonucleotide synthesis. Elemental Impurities/ (ICP-OES/MS) – as per ICH Q3D. ICH compliant stability studies – as per ICH Q1A. GMP Impurities/Assay by HPLC/UPLC – as per ICH Q3. Forced degradation study. Residual solvents analysis by GC as per ICH guidelines.
Compiled from https://www.jubilantbiosys.com
