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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Tests for qualify<strong>in</strong>g <strong>impurities</strong> <strong>in</strong><br />
<strong>drug</strong> substance<br />
Genotoxicity studies (po<strong>in</strong>t mutation,<br />
chromosomal aberration-- Ames assay, <strong>in</strong><br />
vitro cytogenetics y g or mouse lymphoma y p<br />
assay )<br />
General toxicity studies (one species species,<br />
usually 14 to 90 days)<br />
Other specific toxicity endpo<strong>in</strong>ts as<br />
appropriate<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration
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