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 />
F2 = variability between people<br />
F2 = 10<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration