METHOD VALIDATION | REPORTABLE RANGE FOR IMPURITIES AS PER ICH Q2(R2)

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[@mohsentalebi9505]

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

[@vaibhavyalzare1180]

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

[@omkarainapure9192]

Important video sir. Thank you

[@pharmagrowthhub3083]

Most welcome

[@samadhanshinde9069]

Thank u sir

[@deepakchem9100]

Very good information sir

[@pharmagrowthhub3083]

Thanks and welcome, keep watching!

[@machadoafiado3944]

For residual solvents, should the range also be from LQ to 120%? And thanks for the video.

[@pharmagrowthhub3083]

Yes, of course! Because residual solvent is also an impurity.

[@deepaksingla4327]

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?

[@JayeshPatel-fd6fu]

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.

[@JayeshPatel-fd6fu]

Sir please suggest it