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 positive controls <strong>and</strong> doses tested<br />
<strong>in</strong> the Ames assay<br />
2-am<strong>in</strong>oanthracene 1.0 µg/plate<br />
sodium azide 1.0 µg/plate µg p<br />
2-nitr<strong>of</strong>luorene 10 µg/plate<br />
9-am<strong>in</strong>oacrid<strong>in</strong>e 9-am<strong>in</strong>oacrid<strong>in</strong>e 75 µg/plate<br />
methyl methanesulfonate 1,000 µg/plate<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration
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