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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Q3A(R) Q3A(R), Impurities <strong>in</strong> New Drug Substances<br />
Maximum Report<strong>in</strong>g Identification Qualification<br />
Daily Dose Threshold Threshold Threshold<br />
< 2g/day 0.05% 0.1% or 1.0<br />
mg/day <strong>in</strong>take<br />
( (whichever hi h iis<br />
lower)<br />
0.15% or 1.0<br />
mg/day<br />
( (whichever hi h iis<br />
lower)<br />
> 2 g/day 0.03% 0.05% 0.05%<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration
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