Bioequivalence and Bioavailability Forum • Processed Sample Stability

ksreekanth
☆

India,
2020-05-20 15:22
(1430 d 13:31 ago)

Posting: # 21453
Views: 1,935

Processed Sample Stability [Bioanalytics]

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.
Any further PS Stability experiment need to be proved at refrigerator (4°C) condition. Since auto-sampler condition were maintained at 10°C during the Processed Sample analysis.

Edit: Category changed; see also this post #1; please follow the Forum’s Policy. [Helmut]

Helmut
★★★

Vienna, Austria,
2020-05-20 18:29
(1430 d 10:24 ago)

@ ksreekanth
Posting: # 21454
Views: 1,495

Processed Sample Stability

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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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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