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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Q3B(R) Impurities <strong>in</strong> new <strong>drug</strong> <strong>products</strong><br />
Thresholds for Degradation Products <strong>in</strong> New<br />
Drug Products<br />
Qualification Thresholds<br />
Maximum Daily Dose Threshold<br />
< 10 mg 1.0% or 50 µg TDI, whichever is lower<br />
10 mg - 100 mg<br />
> 100 mg - 2 g<br />
> 2 g<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration<br />
0.5% or 200 µg TDI, whichever is lowe<br />
00.2% 2%or3 or 3 mg TDI, TDI whichever is lower<br />
0.15%
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