Impurity Synthesis
Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies offers services during the whole development process and manage impurities synthesis and control. We can identify, isolate and synthesize process related impurities to support process development, analytical control and regulatory requirements.
We are able to provide to our clients a complete CMC Gap Analysis and Risk Assessment included fate and purge studies and impurities markers synthesis. Our main analysis tools are chromatography for the isolation of process impurities, LC/MS-MS/MS and multi-nuclear NMR for characterization. Our expert team masters “Spike and Purge” studies to understand the origin and fate of process-related impurities.
