Posting: # 20760
Here with I had a query with respect to solution stability in Bio analysis method validation.
General approach of evaluating Solution stability is acquiring/analyzing samples which are prepared in organic solvents/Aqueous after dilution from master stock.
But During evaluation of solution stability for one molecule, we faced issue with poor chromatography (peak shape issues).
we observed Poor chromatography after acquisition of few aqueous/organic samples.
Is it acceptable to adopt an alternate approach for evaluation of stock solution stability, where samples are analyzed after spiking to post extraction samples (blank sample processed and spiked with required concentration)?