june1226
请教一个问题：
根据ICH Q3C（R6）草案中内容，只是了解到其PDE发生改变，对其限度仍不甚理解。其中：
三乙胺
Conclusion
The calculated PDE for triethylamine based upon the NOEL of the rat sub-chronic inhalation
study is 62.5 mg/day. Since the proposed PDE is greater than 50 mg/day it is recommended
that triethylamine be placed into Class 3 (“solvents with low toxic potential”) in Table 3 in the
ICH Impurities: Residual Solvents Guideline.
三乙胺PDE为62.5 mg/day，其限度是否可以理解为6250 ppm？
甲基异丁酮
Conclusion
The former PDE of MIBK was greater than 50 mg/day (100 mg/day) and the solvent was
placed in Class 3. The newly calculated PDE of MIBK based upon the Lowest Observed
Adverse Effect Level (LOAEL) for chronic progressive nephropathy in female rats from the
NTP 2-year inhalation study is 22.6 mg/day. Therefore, it is recommended that MIBK be
placed into Class 2 in Table 2 in the ICH Impurities: Residual Solvents Guideline.
甲基异丁酮的PDE为22.6 mg/day，其限度是否可理解为2260 ppm？