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http://www.chromforum.org/viewtopic.php?t=1383

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impürities in ICH

Posted: Thu Jan 27, 2005 8:02 pm
by nihal
Hi,
I need to some information about impürities.I searched in ICH but ı m confused.What means threshold for identification? What means threshold for qualification?Which should be included in specification of drug substance and drug product?
If you reply me ı will be very happy.
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