Bioequivalence and Bioavailability Forum

Hi ksreekanth,

❝ Processed Sample (PS) Stability proved at 10°C (In Auto-sampler), Can we analyze the processed Samples which were stored in refrigerator (4°C) for which stability was not established at refrigerator (4°C) condition.

What are your thoughts – do you remember the Arrhenius equation? However, in the strict sense (!) autosampler stability ≠ processed sample stability.

This reminds me on heated discussions at the Crystal City III workshop along these lines:

“We have validated long-term stability at –20℃.
Can we store samples at –70℃ without re-validation?”

Amazingly some answered “No!”
Was – and is – beyond my intellectual reach. See also Ohlbe’s post.