• Reverse engineering to establish Q&Q formula of Reference listed drug product (Innovator)
• Analytical method development (Assay, RS, OVI, etc by HPLC, UPLC, Ion Chromatography, GC-HS, etc.)
• Impurities isolation (by preparative HPLC)
• API and Unknown impurity characterization in API and Drug products.
• Reference and Impurity standards characterization (by NMR, Mass, IR, UV and Elemental analysis)
• Evaluation, assessment, and analysis of elemental impurities in API and Drug products.
• Chiral and Polymorphic impurities evaluation and analysis.
• Carry over study for API.
• Dissolution method development and multimedia profiling

Analytical method validation, verification and transfer of Assay, Impurities, Residual solvents, Chiral impurities, Genotoxic / Mutagenic / Carcinogenic impurities, etc. for Pharmacopeial and In-house methods