This function focuses on detailed structural elucidation of APIs and intermediates and the comprehensive characterization of impurities, supporting drug development, process optimization, and regulatory compliance. Advanced characterization techniques provide confidence in molecular identity, purity, and safety.
Key Deliverables
- Structural Elucidation: Determining molecular structure using NMR, LC-MS/MS, HRMS, IR, Raman, and X-ray crystallography.
- Impurity Characterization: Identifying unknown impurities, degradation products, and trace contaminants at low concentrations.
- Support for Process Development: Providing insights to optimize synthetic routes, minimize impurity formation, and improve yield.
- Regulatory Compliance: Preparing validated characterization reports for IND, NDA, ANDA, DMF, and regulatory inspections.
- High-Resolution & Sensitive Analysis: Employing cutting-edge techniques to detect and analyze low-level or complex impurities.
- Integration with Analytical & R&D Workflow: Feeding structural and impurity data back to CRD, API development, and manufacturing teams for quality and safety improvements.