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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Qualification <strong>of</strong> <strong>impurities</strong> <strong>in</strong> a<br />
new <strong>drug</strong> substance<br />
“Such studies can be conducted on the<br />
new <strong>drug</strong> substance conta<strong>in</strong><strong>in</strong>g the<br />
<strong>impurities</strong> to be controlled, although<br />
studies t di us<strong>in</strong>g i iisolated l t d i<strong>impurities</strong> iti can<br />
sometimes be appropriate.”<br />
Studies <strong>of</strong> the <strong>drug</strong> substance conta<strong>in</strong><strong>in</strong>g<br />
the impurity preclude traditional risk<br />
assessment.<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration
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