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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Are qualification assays sufficiently<br />
sensitive to detect an impurity p y when the<br />
test employs the new <strong>drug</strong> substance<br />
(DS) conta<strong>in</strong><strong>in</strong>g t i i th the iimpurity? it ?<br />
Typical yp ppositive<br />
controls <strong>and</strong> doses tested <strong>in</strong> an <strong>in</strong><br />
vitro chromosomal aberration assay:<br />
mitomyc<strong>in</strong> y C, , 0.1 µg/ml µg<br />
cyclophosphamide 10 µg/ml<br />
If non toxic toxic, 5 mg/ml <strong>of</strong> DS or 77.5 5 µg/ml <strong>of</strong> impurity<br />
tested<br />
Both materials would detected if parent <strong>drug</strong> is<br />
nontoxic.<br />
Toxicity <strong>of</strong> DS would limit detection <strong>of</strong> impurity<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration
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