Get Empowered: Review Window and the Processing Method | Tip #44

By November 21, 2017


Tip #44: Calculating impurities and setting thresholds for specified impurities (Part 5)

Welcome back to Get Empowered! In the last tip-of-the-week blog for Empower Software, we discussed how to flag impurities in samples using thresholds.

This week we will look at calculating impurities in samples and setting thresholds for specified impurities (part 5).

In the last example we set the reporting, identification, and qualification thresholds for impurities in our sample. The impurity responses 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 easy to do in Empower Software.

Step 1

Let’s start by bringing a sample set into Review, open the Processing Method, click integrate followed by quantitate (Figure 1). Notice that the impurity response for Impurity C is below the Reporting Threshold.

Empower Tips: Impurity response/ Impurity C is below the Reporting Threshold | figure 1

Figure 1

Step 2

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 (Figure 2).

Empower Tips: Impurity Type field/Specified Impurity from the drop down list | figure2

Figure 2

Step 3

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 (Figure 3). While all of the other peaks’ 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.

Empower Tips" Specified Impurities Table | figure 3

Figure 3

Step 4

Return to the main window and click quantitate. Note that the impurity response for Impurity C now exceeds the Reporting Threshold and is flagged (Figure 4).

Empower Tips: Impurity response now exceeds the Reporting Threshold | figure 4

Figure 4

It’s that easy!

 

I learned how to set threshold limits to flag impurities in samples using Empower! #EmpowerTips Click To Tweet

 

Final note: This procedure can be followed using the QuickStart or Pro interface.

 

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Next week in Empower Tip #45: Calculating Impurities (Part 6), Creating impurity groups

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