Method validation

[sapna]

In MV is it necessory to add comparison samples with stability samples in LT stability because it also can be determined using fresly prepared linearity also?

[Celiagg]

Hello!!

Could you repeat the question ? I could not understand the problem well...

CG

[chakri]

It is necessary to keep stability samples(LT) with that of feshly spiked samples so that we can compare the stability samples with that of freshly spiked samples .% of stability should be 90-110%.We are checking the stability of stored samples with that of fresh samples.

[DR]

We typically run a set of standards & samples against fresh preps over the course of several days during validation to assess "solution stability".

As long as the old & fresh solutions agree to within a predetermined percentage of each other, the solutions are deemed "stable" for however old they were when reinjected.

[tima]

Also make sure you do a stability test that is roughly the duration of time you expect to store your samples. So if I have determined the stability of ergosteol-tms is stable for 4 months then I can be assured that I can store my samples and they need to be run prior to time.