In a galenic study I have obtained dissolution results outside the range over which the method was validated (results far below the minimum required). The integration parameters, chosen according to the standard (at the target concentration) are thus not adequate for the samples: the samples are integrated by default. What would be the most correct approach for this problem:
a) to use a standard at the same concentration of these samples ( although the method was not validated at this level)
b) choose the integration parameters according to the samples
c) maintain the integration parameters for the target concentration
Althoug the results are outside the limits, whatever integration I choose, I would appreciate other opinions.

I would choose option d) integrate each sample and standard with parameters appropriate for the individual injection. There is no requirement that the same set of integration parameters be used for all standards and samples. I think each injection should be integrated appropriately.

Good Luck.

To: Tom M.

I'm sorry but I'm not sure I got the right interpretation of your message. When you say "integrate each sample and standard with parameters appropriate for the individual injection" do you mean you use one set of parameters for the standard and another for the samples?