Chromatography Forum

Hello All;
I have a issue with my columns, we are trying to develop a standart procedure for criteria of when you have to regect a column or when you need to Regenerate it; I know thres is now a Standart procedure but I suposse that may be USP or FDA have a criteria bese on N; Taling, selectivity; that we can use to determine when we have to get a new column or do a regeneration.
Usually I develop the method and not concern about this; but now I have to help this this.

I will Appreciate you advices.

Thanks and Best Regards.

As far as I know, there is no "one size fits all" standard. If you are dealing with a validated, regulatory method, you should have system suitability criteria for that method. When you no longer pass system suitability, the column is no longer suitable .

The FDA "suggestions" for system suitability date back to 1987 and are, in my opinion, only there as examples (N > 2,000 !).