Our Analytical labs are well-equipped to support the isolation and purification of impurities by preparative HPLC, as well as their complete analytical characterization and structure elucidation using LC-MS, ICP-MS and NMR (1H, 13C, 1D, 2D, NOE, DEPT).
We offer custom synthesis capabilities of the identified impurities or metabolites.
For novel impurities/ metabolites exceeding the qualification threshold, our facility has GLP-certified safety testing toxicology labs where these can be qualified:
- Genotox studies, including in vitro point mutation and chromosomal aberration
- Sub-chronic studies in mammalian species (rodents) as per ICH Q3A guideline
With over 50 successful IND packages and their supporting CMC services submitted to agencies around the globe, our track record speaks for itself.
For more information visit our website www.advinus.com