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 Solvents--Options Options for Describ<strong>in</strong>g Limits<br />
<strong>of</strong> Class 2 Solvents<br />
Under “option option 2” 2 the DS <strong>and</strong>/or one or<br />
more excipients can exceed the<br />
concentration t ti limit li it <strong>of</strong> f a solvent l t bbut t th the<br />
overall formulated DP can still conform if<br />
the “permitted daily exposure” (PDE) is not<br />
exceeded.<br />
Contrary to EPA philosophy: “dilution is<br />
not the solution to pollution pollution.<br />
”<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration
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