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

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Pharma Growth Hub

Pharma Growth Hub

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Пікірлер: 12
@mohsentalebi9505
@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
@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
@omkarainapure9192 7 ай бұрын
Important video sir. Thank you
@pharmagrowthhub3083
@pharmagrowthhub3083 7 ай бұрын
Most welcome
@deepakchem9100
@deepakchem9100 7 ай бұрын
Very good information sir
@pharmagrowthhub3083
@pharmagrowthhub3083 7 ай бұрын
Thanks and welcome, keep watching!
@machadoafiado3944
@machadoafiado3944 7 ай бұрын
For residual solvents, should the range also be from LQ to 120%? And thanks for the video.
@pharmagrowthhub3083
@pharmagrowthhub3083 7 ай бұрын
Yes, of course! Because residual solvent is also an impurity.
@samadhanshinde9069
@samadhanshinde9069 7 ай бұрын
Thank u sir
@deepaksingla4327
@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?
@JayeshPatel-fd6fu
@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
@JayeshPatel-fd6fu 4 ай бұрын
Sir please suggest it
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