Get Empowered: Review Window and the Processing Method | Tip #44
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.
- Tip 40: Calculating unnamed impurities in samples (part 1)
- Tip 41: Calculating impurities in samples by % adjusted area (part 2)
- Tip 42: Calculating impurities in samples by % area against the main peak (part 3)
- Tip 43: Calculating impurities in samples and setting thresholds (part 4)
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.
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.
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).
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.
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).
It’s that easy!
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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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