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Accelerating ScienceAnalyteGuru / Chromatography Data System / USP Chapter <621>: Chromeleon CDS Flexibility Simplifies Calculation of Updated Values

USP Chapter <621>: Chromeleon CDS Flexibility Simplifies Calculation of Updated Values

By Crystal Welch, Global Product Marketing Manager – CMD Software, Thermo Fisher Scientific 12.13.2023

Another USP Chapter <621> update?

Starting with the obvious – the USP <621> chapter on system suitability calculations has (once again!) been updated. 

I know we were all prepared for the switch to harmonize the calculations for Resolution, Plate count, and signal-to-noise from the USP to match the EP and JP, but on Aug. 25, 2023, the USP announced there would be a return to the prior calculation for USP signal-to-noise with an official, revised, version of <621>1 being posted on Oct. 1. The rest of the harmonized calculations have not been impacted and the implementation date for methods is set for May 1, 2025.  

Chromatography calculations

For those wishing to report the harmonized Plate count and Resolution calculation in Chromeleon chromatography data system (CDS), configure your Plates and Resolution columns to report the “EP Formula” instead of the “USP Formula” as outlined by our v.2.0 support article USP 621 Harmonization – Chromeleon Guidance2 and demonstrated in the video below.

Video: Calculation options featuring USP <621> calculations

Chromeleon system suitability calculation options
Presents user knowledge to meet changing regulatory updates with Chromeleon CDS.
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Chromeleon CDS was engineered to give flexible options and the preceding video goes through some of the ways to calculate updated values without having to upgrade or change anything. All of these skills can be applied to reports, too.

Resources

For free access to our public knowledge base2, click here.

For users with support contracts who would like to search through our support knowledge base 3, click here.

To find out more about our Chromeleon CDS service contracts, click here.

  1. You must have a registered USP account (free) to view.
  2. You must register a Thermo Scientific account (free) to see articles in our public knowledge base.
  3. You must have a support contract account to access our support knowledge base.

Crystal Welch

Crystal Welch started her industry journey in large molecule manufacturing and quality, working through several more years in process development and contributing to projects in validation, quality system initiatives, process improvements, product characterization, and regulatory submissions. After more than a decade of being a customer, she then offered consultation and support to the same departments in the field, helping others to accomplish projects in their own facilities. Now she spends her time reading regulatory policy updates, following cutting edge informatics product development, and summarizing user feedback to provide improvement suggestions with the goal to make scientists' lives easier.
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