Article | October 31, 2022

Scaling Up Your Methods with USP <621> - Part 3: Software

Source: Waters Corporation
Lab Software GettyImages-1180547354

Learn about modifications to certain calculations and how they will be addressed using our flagship chromatography data system. The changes are summarized below:

  • Modification to formulas for resolution and plate count using width at 50% height rather than tangent.
  • Signal-to-noise to be observed over a distance equal to 20 times the width at 50% height instead of 5. (What is the impact on vendor system qualifications?)
  • Tailing is now called symmetry factor instead of tailing, harmonizing with European and Japanese Pharmacopoeias.

Relevant naming conventions and calculations will be maintained within our software to help customers updating their company SOPs to prevent disruption to operations.

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