Typically residual solvent testing is not performed during requalification unless levels are much greater than 0.1% and early development data shows a significant change with time.
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Original Message:
Sent: 01-07-2025 13:38
From: Anonymous Member
Subject: Reference standard requalification for small molecules
This message was posted by a user wishing to remain anonymous
Hello,
What is the general practice for reanalyzing residual solvents during re-qualification of a reference standard for small molecules. I have seen different approaches where residual solvents is re-analyzed at time of requalification only if it is >10,000 ppm at release testing. For others, I have seen re-analyze residual solvents even if > 0.1%.
Thanks