Chromatography Forum

Hi all,
It has been quite long since my last post!!. I have a question,
In our drug product related substance chromatogram there are some peaks observed sample as well as in placebo. However, the peak response is higher in the sample (40 to 50% higher). Should we have to report it? Anybody faced such issues?. How to go ahead about that?

Appreciate valid responses,

Thanks
Vijayak

That strongly implies that your sample contains peaks that co-elute with peaks from the placebo. I'm sorry to be the bearer of bad news, but at a minimum, that "excess" area should be reported. If it represents a sufficient area to be identified, I would recommend that you develop an orthogonal method to separate what is sample-related from the placebo.