Chromatography Forum

As per USP 37 NF 32. What does it mean for their System Suitability Guideline as mentioned below:

"Whenever, there is a significant change in the chromatographic system (equipment, mobile phase component, or other components) or in a critical reagent, System Suitability is to be reestablished."

During validation we have, Precision, Day 2 (Intermediate Precision), Solution Stability (24 hours standing of day 1 sample with fresh standard), Robustness. Do I still need to perform suitability test if.

1. I'm injecting same sample preparation again the next day with new standard preparation but still the same HPLC system and mobile phase?

2. I'm injecting new sample and standard preparation but still the same HPLC system and mobile phase?


THanks.

I would highly recommend performing system suitability, but there may be a few variables.

1) If your instrument has been continually running since your last run finished with all of the same parameters (flow rate, column temp, detector left on, etc.) then it may be possible for you to say your system is still suitable. You'd still have to do your "bracketing standards" to ensure they meet your requirements. Note that some places may say this is not acceptable.

2) If your instrument was stopped or a parameter was changed (i.e. you slowed the flow rate to conserve mobile phase or you turned off your UV lamp) then you need to reestablish suitability.

My recommendation would be to stay on the safe side and redo suitability.