Bioequivalence and Bioavailability Forum

Dear Mr. Kumar,

The purpose of system stabilization is to handle the back pressure that is created in the system. A high back pressure will always cause increase in area and area ratios which will come down significantly after a few injections. The idea of system stabilization is to bring down the area ratios to normal, by subsequent injections so that the area ratios are stabilized.

On the other hand system suitability is done on a stabilized system, to access if the system is suitable with respect to column, mobile phase, area ratio and RT of drug and IS.

An SOP should be in place defining the procedure for performing system stabilization and the acceptance criteria. No subject samples should be used for stabilization.

Reporting of results of system stabilization would add clarity to the data and the regulators won't be left surprised as to how the system was stabilized.

Regards
P.S.Srinivas