METHOD VALIDATION | REPORTABLE RANGE FOR IMPURITIES AS PER ICH Q2(R2)
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- เผยแพร่เมื่อ 2 ม.ค. 2024
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Thank you for the great content.
Should we spike the impurity in the drug product or in the vehicle when validating linearity for known impurities?
Thank you
In this case consider loq at 0.05% but while calculating accuracy don't forget to remove 0.4% of your impurity as already 0.4% impurity is there in control sample
Important video sir. Thank you
Most welcome
If the relative response factor is outside the range 0.8-1.2, then a
correction factor should be applied. If an impurity/degradation product is
overestimated, it may be acceptable not to use a correction factor
Sir which correction factor needs to apply?
Thank u sir
For residual solvents, should the range also be from LQ to 120%?
And thanks for the video.
Yes, of course! Because residual solvent is also an impurity.
Very good information sir
Thanks and welcome, keep watching!
Dear sir Nice information. I have one Question. While one impurity limit Not more than 0.5% .in as such sample amount present 0.4%. My LOQ is precise that impurity at 0.05% but accuracy not meet due to Higher amount impurity of sample . That time what can we do. Is that consider LQ is 0.05% kindly suggest it.
Sir please suggest it