testing stability in method validation
Posted: Thu Jul 15, 2010 1:27 pm
Dear all,
in our lab, when we want to determine the stability of an analyte after a period of, say, 24 hours, we do the following:
we measure QC samples at time zero (3 injections/concentration) - store that sample solutions (or prepared samples) at predefined conditions - reinject the samples after 24 hours (again 3 injections/conc.) and quantify using a freshly made calibration curve on that day - compare the mean result of these injections with that from time zero
Someone told me that I have to quantify the injections from time 24h using the original calib curve (from time zero) and that I have to compare the results with the nominal concentration.
What is the most common procedure in regulated labs?
Thank you in advance for your input.
in our lab, when we want to determine the stability of an analyte after a period of, say, 24 hours, we do the following:
we measure QC samples at time zero (3 injections/concentration) - store that sample solutions (or prepared samples) at predefined conditions - reinject the samples after 24 hours (again 3 injections/conc.) and quantify using a freshly made calibration curve on that day - compare the mean result of these injections with that from time zero
Someone told me that I have to quantify the injections from time 24h using the original calib curve (from time zero) and that I have to compare the results with the nominal concentration.
What is the most common procedure in regulated labs?
Thank you in advance for your input.