Empower Tip: Review Window and the Processing Method

In the last example, we set the reporting, identification, and qualification thresholds for impurities in our sample. The impurity response for all impurity peaks are compared to these thresholds. What if we had a potentially toxic impurity and needed to set lower thresholds for that one impurity? It’s very easy to do.

Let’s start by bringing a sample set into Review, open the processing method, click integrate followed by quantitate. Notice that the impurity response for Impurity C is below the Reporting Threshold.

Click the Processing Method tool and then the Components tab. Finally, locate the Impurity Type field. For Impurity C, select Specified Impurity from the drop down list.

Click the Impurity tab and note that there is now a line in the Specified Impurities Table. Enter the threshold values for this peak accordingly. While all of the other peak’s impurity responses will be compared to the ICH Threshold values, the impurity response for this one peak will be compared to the values entered in the Specified Impurities Table.

Return to the main window and click Quantitate. Note that the impurity response for Impurity C now exceeds the Reporting Threshold and is flagged.

It’s that easy!