We are following a GC method in the European Pharmacopeia which involves gas chromatography of some amines. The suitability requirement in this monograph is that a certain resolution be achieved. However, in the chapter on chromatographic separations (chapter 2.2.46) there are requirements listed for tailing as well as for limit of detection and limit of quantification. I interpret that the suitability requirements that are listed in the monograph are the only ones that are necessary to be met, but I am being told that we also need to meet the tailing factor requirement and the detection limit requirements. Can anyone tell me what their interpretation would be. The problem we are having is that, no matter what column we have tried, or how we have adjusted the CG, we can not achieve the tailing requirement.

Thank you in advance for your help on this.