Empower Tip: Questions from Our Readers

Question: How do you quantitate impurities against the main component?

Another great question and there are two possible scenarios.

Let me show you how it is done.

If the impurities are listed in the Components tab of the Processing Method, go to the Curve Reference field and select the API/main component for the impurity (or impurities) so that Empower quantitates the impurities against the calibration curve for the main component. The Relative Response field is used to multiply the calculated amount by a factor, the default is 1.

If the impurities are not listed in the Components tab of the Processing Method, go to the Default Peak field and check the box for the API/main component. Then set the Default Start and Default End fields to include the time frame in which the impurities elute. Any peaks which elute in that region will be quantified against the calibration curve for the API.

Go to the Impurity tab and set the Impurity Response to Amount. Select the API as the Main Component. You can then set the ICH Thresholds as per your SOP.

Quantitate the sample and we see the Amount of impurities calculated in the sample.

It’s that easy!