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Permitted changes in HPLC methods from the 11th edition of the European Pharmacopoeia
Allowable Adjustments to HPLC Methods 11. Edition in the European Pharmacopoeia
On January 1st 2023 the 11th edition of the European Pharmacopoeia (Ph. Eur.) took effect. In course of revision, it was harmonised with the United States Pharmacopoeia (USP), British Pharmacopoeia (BP) and Japanese Pharmacopoeia (JP) so that the general chapter 2.2.46 on chromatographic separation techniques received an update. The chapter for example specifies the requirements for system suitability tests and allowable modifications for method changes and optimisations.
To keep you up to date on the permitted changes, YMC's technical experts have compiled for you these new rules in a helpful technical note, which lists all relevant allowed changes on one page.