Key Capabilities
- Identification and characterization of process-related and degradation impurities
- Structural elucidation using advanced analytical techniques (LC-MS, GC-MS, NMR, etc.)
- Synthesis of impurity standards and reference compounds
- Development of impurity profiles for APIs and intermediates
- Establishment of impurity control strategies as per regulatory guidelines
- Forced degradation and stability studies
- Trace-level impurity detection and quantification
- Genotoxic impurity (GTI) identification and control
- Nitrosamine impurity assessment