Empower Tip: USP Chapter 621 for Chromatography

In this tip for Empower Chromatography Data System (CDS), we continue our series on the upcoming changes to USP Chapter 621 for Chromatography.

In this tip, we will discuss how to comply with USP requirements using your current version of Empower.

To recap the changes from Tip 301, they are as follows:

Resolution, Relative Resolution and Plate Count will use width at Half Height

Width at Tangent is no longer used for any calculation

Plate Count will be called Plate Number

Tailing Factor will be called Symmetry Factor, no change to the calculation

The Half Height Multiplier for signal-to-noise will change from 5 to 20, no change to the calculation

There are fields already calculated in Empower which you can report to comply with the changes using the version of Empower you have today. You can rename them accordingly:

USP Resolution (HH), Resolution per both the EP and JP all use peak width at half height

Relative Resolution uses peak width at half height

EP Plate Count and JP Plate Count use peak width at half height

USP Tailing, Symmetry Factor per both the EP and JP

An alternative for the calculation of Resolution is to create a Custom Field. Please remember that any Custom Field should be validated before putting it into routine use.

An alternative for the calculation of Plate Count is to create a Custom Field. Again, please validate the Custom Field before it is put into routine use.

An example is shown reporting USP Resolution (HH), EP Plate Count and USP s/n.

The Half Height Multiplier has been changed from 5 to 20 in the Processing Method to comply with the new requirement.

It’s that easy!