Attachment 2: Illustration of Reporting Degradation Product Results for Identification and Qualifica

The attachment is only illustrative and is not intended to serve as template how results on degradation products should be presented in an application file .2 To verify if a threshold is exceeded , a reported result has to be evaluated against the thresholds as follows : when the threshold is described in%.The reported result rounded to the same decimal place as the threshold should be compared directly to the threshold .When the threshold is described in TDI , the reported result should be converted to TDI .So the qualification threshold expressed in TDI ( 3mg ) is not exceeded .