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

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

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Пікірлер: 12

@mohsentalebi9505 4 ай бұрын

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 4 ай бұрын

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 7 ай бұрын

Important video sir. Thank you

@pharmagrowthhub3083 7 ай бұрын

Most welcome

@machadoafiado3944 7 ай бұрын

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

@pharmagrowthhub3083 7 ай бұрын

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

@JayeshPatel-fd6fu 6 ай бұрын

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 4 ай бұрын

Sir please suggest it

@deepaksingla4327 7 ай бұрын

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?