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full validation or verification of residual solvents USP

http://www.chromforum.org/viewtopic.php?t=4686

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full validation or verification of residual solvents USP

Posted: Tue Oct 03, 2006 10:53 pm
by srdales
When does one go into a full validation (recovery etc) versus a verification or only chapt 1225 for API on residual solvent?

How much can on vary? Different stationary phase? Different temp.? etc?

Is there a reference on how much variation is allowed before full validation is required?

Posted: Tue Oct 17, 2006 11:08 am
by cullenp
If your working from the USP residual solvents monograph your not really meant to change anything. The method listed in the monograph for the substance being examined should contain all the relevant information i.e Column, temperatures etc. If you need to vary any of these then you must validate the method. As methods contained in the USP/EP and JP are vaildated methods.

Posted: Sat Oct 21, 2006 2:51 pm
by ntruong
If residual solvent analysis becomes a routine in your lab, I would validate this method. By doing this, you don't have to worry about varying parameters.
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