YMC i-Mail May 2023

Technical Note

Permitted changes in HPLC methods from the 11th ed. of 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, our technical experts compiled for you these new rules in a helpful technical note, which lists all relevant allowed changes on one page.

To obtain a full copy of this Technical Note, please follow the link below.


New Expert Tip

Guideline for buffer selection for RP methods

When developing a new method, the selection of eluents is always a key factor. pH has an especially important influence on the retention when working with ionisable compounds. At a pH ± 2 units around the analyte’s pKa, even small changes in pH can lead to drastic retention shifts.

This guideline includes the following helpful tips and overviews:

  • How to select the optimum pH
  • Selecting the corresponding optimum buffer
  • A list of common buffers, their buffer range and standard concentration and their MS compatibility

For further helpful technical documents such as Expert Tips or Technical Notes, check out our Expertise Portal


Figure: Illustration of the retention change when varying the pH for an acidic compound (red) and a basic compound (blue).


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