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 />
F4 = a factor applied <strong>in</strong> cases <strong>of</strong> severe toxicity,<br />
non-genotoxic t i carc<strong>in</strong>ogenicity i i it or teratogenicity<br />
t t i it<br />
F4 = 1 for fetal toxicity yassociated with maternal toxicity y<br />
F4 = 5 for fetal toxicity without maternal toxicity<br />
F4 = 5 ffor tteratogenic t i effect ff t with ith maternal t l toxicity t i it<br />
F4 = 10 for teratogenic effect without maternal toxicity<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration
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