The harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), on 28 September 2021. The coordinating pharmacopoeia for this text was the Ph. Eur.
During a joint PDG–industry meeting in 2009, the PDG was encouraged to add harmonisation of the three regional chapters on chromatography to the PDG work programme. Although the chapters in question differed in content and format, it was considered feasible to develop a chapter describing core requirements applicable for TLC, HPLC and GC.
After discussion, it was agreed not to include more general (textbook type) descriptions of individual techniques as each of the PDG pharmacopoeias has its own approach, decided at regional level.
These harmonised requirements promote the development of individual monographs with a consistent approach and enhance understanding of basic requirements by users in all three regions.
The successful completion of the complex work demonstrates once again the commitment of the participating pharmacopoeias to harmonisation and the PDG – ultimately benefiting patients and industry. For more information, read the press release “PDG signs-off on milestone harmonised general chapter on chromatography”.