ATTACHMENT 2 Illustration of Reporting Impurity Results for Identification and Qualification in an A

The attachment is only illustrative and is not intended to serve as template how results on impurities should be presented in an application file .2 ) To verify if a threshold is exceeded , a reported result has to b evaluated against the thresholds as follows : when the threshold i described in%.The reported result rounded to the same decimal place as the threshold should be compared directly to the threshold .So the qualification threshold expressed in TDI ( 1.0 mg ) is not exceeded .