USP Chapter 621 for Chromatography: USP Requirements - Tip302

OBJECTIVE or GOAL

Comply with USP requirements using your current version of Empower.

ENVIRONMENT

• Empower
• Tip of the Week #302

PROCEDURE

STEP 1
A recap of the changes from Tip #30 (Figure 1):

• 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; there is no change to the calculation.
• The Half Height Multiplier for signal-to-noise changes from 5 to 20; there is no change to the calculation. 

STEP 2
To comply with the changes using the version of Empower you have today, there are fields already calculated in Empower that you can report. You can rename them accordingly (Figure 2):

• USP Resolution (HH) and 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 and Symmetry Factor per both the EP and JP.

STEP 3
An alternative for the calculation of Resolution is to create a Custom Field. Remember that any Custom Field should be validated before putting it into routine use (Figure 3).

STEP 4
An alternative for the calculation of Plate Count is to create a Custom Field. Again, validate the Custom Field before you put it into routine use (Figure 4). 

STEP 5
This example shows reporting of USP Resolution (HH), EP Plate Count, and USP s/n (Figure 5):
 

STEP 6
The Half Height Multiplier has been changed from 5 to 20 in the Processing Method, to comply with the new requirement (Figure 6).
 

ADDITIONAL INFORMATION

This can be done with either the Pro or QuickStart interface.