dissolution method

[moonchips]

Is a chromatogram with an unresolved impurity (~1.5%) coeluting with the main peak acceptable in a dissolution method?

our sample is pretty dirty (phase one). shall I try to separate all impurities or just leave it?

Thanks,

[danko]

If you have a purity determination, applying to the same drug/tablet using another chromatographic method, you don’t have to worry about the impurity in question in the dissolution determination.

Best Regards