Regulation of impurities in drug substances and products
Regulation of impurities in drug substances and products
Regulation of impurities in drug substances and products
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Detection <strong>of</strong> genotoxic <strong>impurities</strong><br />
ICH Q3A(R2) <strong>and</strong> ICH Q3B(R2): identification<br />
<strong>of</strong> an impurity when it achieves a level <strong>of</strong> 0.1<br />
percent or 1 mg per day (whichever is lower) at<br />
a daily dose <strong>of</strong> less than or equal to 2 grams for<br />
the <strong>drug</strong> g substance or 0.15 percent p to 1 percent p<br />
for the <strong>drug</strong> product.<br />
A genotoxic or carc<strong>in</strong>ogenic impurity could be<br />
present <strong>in</strong> a <strong>drug</strong> product at a level result<strong>in</strong>g <strong>in</strong><br />
exposures up to 33,000 000 µg per day without<br />
need<strong>in</strong>g identification!<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration
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