Bioequivalence and Bioavailability Forum

❝ 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).

Just check content of mobile phase and of reconstitute solution/elution solution. difference in content/proportion ratio may give peak shape issue in aqueous sample.

❝ 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)?

It is acceptable if justified scientifically. Meanwhile check matrix effect by comparing aqueous sample with post spiked sample. I expect post spiked sample may have poor peak shape.

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]