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 Residual<br />
Solvents, Risk Assessment for Class 2<br />
Solvents, F1: extrapolation between species:<br />
Phylogenetic k<strong>in</strong>ship? No, surface area!<br />
F1 = 12<br />
F1 = 2<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration<br />
F1 = 2.5
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