Elemental Impurities

Elemental impurities (ICHQ3D)

Elemental impurities  may  arise  from  residual catalysts  that  were  added intentionally  in  synthesis, or  may  be  present  as  impurities, e.g., through  interactions  with processing equipment  or  container/closure  systems  or  by  being present  in  components  of  the  drug product.

The analytical procedure for Elemental Impurities implemented in our lab, ICP-MS analysis after microwave assisted digestion, allows the accurate determination of the elements defined in ICH Q3D guidelines and the additional ones required by EMA.