How to Quantitate Impurities Against the Main Component - Tip78

OBJECTIVE or GOAL

Welcome back to Get Empowered! In the last Empower tip-of-the-week post for Empower Software, we answered a submitted reader question and learned how to summarize specified and unspecified impurities in a sample and quantitate them against the main component. (Tip #77) (See the link at the bottom of our post to ask your own question, or to provide a tip of your own!)

In this week’s tip, I will answer another question pertaining to calculating impurities.

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.

ENVIRONMENT

• Empower

PROCEDURE

1. 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 Software 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.

2. 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 that elute in that region will be quantified against the calibration curve for the API.

3. 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.

4. Quantitate the sample. We see the Amount of impurities calculated in the sample.

It’s that easy!

ADDITIONAL INFORMATION

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