Investigational
novartisnovartisnovartis
novartisnovartisnovartis
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Translate Threshold of Toxicological<br />
Concern (TTC) in ppm?<br />
NOVARTIS<br />
Maximum levels of impurity in a chronic use drug<br />
(scenario for “PDE’s” between 0.05 and 50 ug/day)<br />
PDE* for<br />
impurity<br />
(µg/day)<br />
Max. content (in ppm) of impurity in drug substance if<br />
daily dose of drug (g/day) is:<br />
0.1<br />
1<br />
2<br />
5<br />
0.05<br />
0.5<br />
0.05 0.025 0.01<br />
0.5<br />
5<br />
0.5<br />
0.25<br />
0.1<br />
1.5<br />
15<br />
1.5<br />
0.75<br />
0.3<br />
5<br />
50<br />
5<br />
2.5<br />
1<br />
50<br />
500<br />
50<br />
25<br />
10<br />
* Denotes “Permitted Daily Exposure<br />
To be used if Threshold of Toxicological Concern will be generally accepted<br />
L. Müller, Swissmedic, 21-Oct-2003
Change language