Analytical Research
- Excipient Compatibility Study
- Dissolution profile
- Hardness and Friability testing
- Evaluation of NCE formulations for Clinical, Pharmacological and Toxicology study
- Sameness study to establish comparability with RLD
- Development and validation of Assay, Related Substances, & Particle size determination
- Extractable & Leachable study
- Characterization and Structural elucidation for API, Intermediate, KSM and Potential
- Impurities
- Characterization of Peptides (primary and higher order structure)
- Designing specifications for KSM, Intermediates and API as per regulatory compliance of respective agencies
- Development and validation of methods for determining PGI, Nitrosoamine Impurities
- (Small-Molecules nitrosamines & NDSRIs), Elemental Impurities & Residual solvents
- In-silico Genotoxic Impurity (GTI) structure evaluation
- Polymorphism and Solid-State Characterization.
- Qualitative and Quantitative evaluation of Polymorphism
- Evaluation as per Pharmacopoeia for marketing authorization in respective countries
- Stability study to determine Shelf-life & Retest period
- Evaluation of Physico-chemical properties