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><br />
<strong>products</strong> <strong>products</strong>-<br />
Thresholds for Degradation Products <strong>in</strong> New<br />
Drug Products<br />
Report<strong>in</strong>g Threshold<br />
Maximum Daily y Dose Threshold<br />
< 1 g<br />
0.1%<br />
> 1g 0.05%<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration
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