Avert unanticipated impurities in API and drug products that stall development or result in recalls with Covance's impurity isolation and identification service. Utilize Covance's state of the art chromatographic and spectroscopic techniques and the scientific insight of Covance specialists to isolate and identify impurities resulting from API synthesis, product manufacturing, or degradation and if necessary qualify impurities.
- Semi-preparative chromatography system with fraction collector
- LC/MS or conventional mass spectroscopy
- Infrared spectroscopy for functional group identification
- Carbon-back bone and hydrogen arrangement determination through 1HNMR and 13C NMR
- Elemental analysis
As described in the ICH guidance, impurities that are not able to be removed or prevented from forming need to be qualified through an appropriate toxicology study. Use Covance's toxicology team to assist in development of the safety profile for impurities.