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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Q3C, Impurities: Guidel<strong>in</strong>e for<br />
RResidual id l SSolvents, l t Ri Risk k AAssessment t ffo<br />
Class Cass2 Solvents So e s<br />
F5 = a factor applied if the no-effect level was not<br />
established tblihd<br />
F5 = 10 when only ya LOEL is available, <strong>and</strong> depend<strong>in</strong>g p gon<br />
the<br />
severity <strong>of</strong> the toxicity.<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration<br />
No<br />
Effect
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