Empower Tip: USP Chapter 621 for Chromatography

In this tip for Empower Chromatography Data System (CDS), we have an update concerning the changes to USP Chapter 621,

In this tip, we have an update concerning the changes to USP Chapter 621 regarding the calculation of signal-to-noise (S/N) ratio. This applies to the EP chapter 2.2.46 as well.

USP Chapter 621

As of 1 December 2022, the revised USP chapter 621 was published. One of the changes is the half-height multiplier for the signal-to-noise ratio changed from 5 to 20.

After much consideration, the USP has decided that as of 1 April 2023, they will revert to a half-height multiplier of 5.

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EP Chapter 2.2.46

As of 1 January 2023, the revised EP Chapter 2.2.46 was published with a half-height multiplier change from 5 to 20 (Refer to figure 1).

The EP has decided to revert to a half-height multiplier of 5 as of 1 January 2024 (Refer to figure 2).

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So, what to do until the changes become official?

By convention it is acceptable to follow the 'future' guidance, however, Waters cannot represent or speak for FDA in this regard. This is a discussion you should have internally with your compliance officer.