The USP, JP and Ph.Eur Chromatographers Sing in Perfect Harmony!

13 January 2023

Christmas came early this year for chromatographers. After a 30 year career-long wait, on 01/12/2022, the USP General Chapter <621>Chromatography, and the JP Chromatography General Chapter were finally fully harmonised with the Ph Eur. General Chapter 2.2.46 Chromatographic Separation Techniques.

The good news includes that allowable adjustments of chromatographic conditions, which were especially complex for HPLC, are now fully harmonised. Another good outcome is that system suitability calculations are now equivalent and data systems will no longer have to run with different sets of algorithms for USP, JP and Ph Eur. calculations and system suitability factors and results can be directly compared for all three pharmacopeia.

To add a bit more excitement to our 2023 analysis, on 01/01/2023, the Ph. Eur. 11.0 implemented a wider range for the blank noise window used for Signal to Noise calculations, and since the USP <621> are now harmonized, this will also apply to the USP and JP calculation, changing the window for determining noise in the blank from 5 to 20 times peak width at half height.

One problem is that system suitability calculation algorithms of data systems will have to be updated. It will be interesting to see how long it takes the instrument manufacturers to do this.

This harmonisation should have been implemented a long time ago but at least now USP, JP and Ph Eur Chromatographers will Sing in Perfect Harmony!

Frank Judge

Consultant Chemist- Chromatography at Butterworth Laboratories Ltd