This function focuses on the identification, quantification, and assessment of impurities in APIs, intermediates, and drug products. Impurity profiling ensures product quality, safety, and adherence to global regulatory standards, supporting both development and commercial manufacturing.
Key Deliverables
- Identification of Impurities: Detecting related substances, process- and degradation-related impurities, and potential genotoxic impurities using HPLC, LC-MS, GC-MS, NMR, and other advanced techniques.
- Quantification & Characterization: Accurate measurement of impurity levels and structural elucidation to support safety assessments.
- Impurity Risk Assessment: Evaluating potential safety and regulatory impact of impurities, including genotoxicity and mutagenicity.
- Regulatory Support: Providing detailed impurity profiles and evaluation reports for IND, NDA, ANDA, and DMF submissions.
- Process Monitoring & Optimization: Guiding process development to minimize impurity formation and enhance API quality.
- Documentation & Compliance: Preparing validated analytical reports and data packages for regulatory inspections and quality audits.