By Antonella on Friday, September 3, 1999 - 12:15 am:
First question: how can I define and show the DAD purity of my sample during the stress tests in a validation?
Second question: does it exist a rule for the impurity validation? In the tests of range, linearity, repeatability, etc. is it necessary make its in the presence of principal peak or not and why?
Thank you
By pkratra on Tuesday, January 18, 2000 - 12:49 am:
Dear Antonella
1)By determining the peak purity of main peak to confirm the absence of any other peak coeluting with the main peak even after degradation.
2)It is necessary to show that your method is specific and that in sample spiked with all known impurities the peak purity of all the known impurities including the main peak should pass.No such DAD purity tests are required for linearity, range, repeatability etc.
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