三乙胺是三类溶剂吗，有没有收录进最新版的ICH Q3C 残留溶剂指南

safsaf · 发表于 2017-4-8 11:03:14

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从网上看到ICH 拟将三乙胺列为三类溶剂，最新版的ICH Q3C有没有将三乙胺正式列为三类溶剂，最新版本是2016年10月发布的 ICH Q3C_R6__Step_4吗，ICH Q3C_R6__Step_4是正式最终版本吗？

zysx01234 · 发表于 2017-4-8 11:04:10

我反正是列为3类了

lllllyyyyy · 发表于 2017-4-8 14:44:20

edqm
320ppm

safsaf · 发表于 2017-4-8 15:00:58

lllllyyyyy 发表于 2017-4-8 14:44
edqm
320ppm

EDQM 320ppm 来自哪个文件或药典

lllllyyyyy · 发表于 2017-4-8 15:30:18

本帖最后由 lllllyyyyy 于 2017-4-8 15:32 编辑

PA/PH/CEP(04)14R
Concerning residual triethylamine, a permitted daily exposure (PDE) of 3.2 mg/day giving a limit of 320 ppm (for a 10 g daily dose) was calculated from repeated Dose Toxicity and Reproductive Toxicity data. This limit of 320 ppm should therefore be used as a reference limit. Higher limits should be justified by batch analysis data and the maximum daily dose of the concerned substance. It should be noted that this limit is not immediately applicable to other organic bases for which limits should be calculated on available toxicological data.

safsaf · 发表于 2017-4-8 16:09:27

lllllyyyyy 发表于 2017-4-8 15:30
PA/PH/CEP(04)14R
Concerning residual triethylamine, a permitted daily exposure (PDE) of 3.2 mg/day ...

谢谢，学习了

terbiumcf · 发表于 2017-4-8 16:27:56

感谢，学习了！

beiwei5du · 发表于 2017-7-29 13:26:25

lllllyyyyy 发表于 2017-4-8 15:30
PA/PH/CEP(04)14R
Concerning residual triethylamine, a permitted daily exposure (PDE) of 3.2 mg/day ...

Conclusion
The calculated PDE for TEA 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 TEA be placed into Class 3 (“solvents with low toxic potential”) in Table 3 in the ICH Impurities: Residual Solvents Guideline.
为什么你提供的数据PDE 3.2 mg/day 和ICH Q3C的62.5mg/day有如此大差距呢？？？

383582973 · 发表于 2018-8-22 19:07:32

进来看看，学习

herozxq · 发表于 2018-8-23 13:11:00

色谱微信群，加zorro_zheng，加时请提示制药

xidio114 · 发表于 2019-8-18 22:22:42

是3类

[药典/标准文件] 三乙胺是三类溶剂吗，有没有收录进最新版的ICH Q3C 残留溶剂指南

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