ATTACHMENT 3 Decision Tree for Identification and Qualification

A ) If considered desirable , a minimum screen ( e . g . , genotoxic potential ) , should be conducted .On a case-by-case basis single-dose studies can be appropriate , especially for single-dose drugs In general , a minimum duration of 14 days and a maximum duration o 90 days would be considered appropriate .D ) For example , do known safety data for this impurity or it structural class preclude human exposure at the concentration present ?