Empower 3.8.0: Updates to System Suitability calculations - Tip351
OBJECTIVE or GOAL
Updates to System Suitability calculations because of the changes to USP Chapter <621> Chromatography.
ENVIRONMENT
- Empower
- Empower Tip of the Week #351
PROCEDURE
STEP 1
Empower 3.8.0 uses the revised language as per the USP, i.e., Plate Number and Symmetry Factor. All fields in versions prior to 3.8.0 are available for legacy data (figure 1).
STEP 2
Resolution now uses peak width at half height. The USP calculation is on the left and the Empower calculation on the right (figure 2).
STEP 3
Plate Number, formerly Plate Count, now uses peak width at half height. The USP calculation is on the left and the Empower calculation on the right. USP Plate Count is a legacy field (figure 3).
STEP 4
Symmetry Factor, formerly USP Tailing, has no change to the calculation (figure 4).
STEP 5
Signal-to-noise ratio has a major change. Noise should be calculated from a blank injection at the expected retention time of a peak. There is a time range around that expected retention time which is peak width at half height times 5 (figure 5).
STEP 6
Empower 3.7.0, which was released in 2022, added the calculations for the Chinese Pharmacopeia. This is now an available selection on the Suitability tab of the Processing Method as can be seen on the left side of the figure. The new fields found in Empower 3.8.0 can be seen in the Peaks table in Review as can be seen on the right side of the figure (figure 6).
ADDITIONAL INFORMATION