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dissolution method

Posted: Fri Apr 16, 2010 2:01 pm
by 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,

Posted: Sat Apr 17, 2010 10:09 am
by 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