Triethyamine

[vanjas]

Hi !!
My question is kind of simple..
There is no limt for triethylamine in the ICH guideline.
Is there any reference that I can use its specification on quality control??

Any advise would be appreciated for me..
Thanks for your attention on this matter in advance..

[DR]

If TEA levels are determining whether or not you are achieving a separation, you're using too much and you need to reconsider either your mobile phase system or column choice. All TEA is supposed to do is allow otherwise tailing peaks to "behave". Put in enough to ensure that and no more. Be aware that TEA can have lasting effects on columns.

[sg]

That is true triethylamine is not covered currently by ICH Q3C. In this case normally you can assume it is class 3 solvent which is 5000ppm level. If you have tox data, you can use it if it is lower than 5000ppm. According to the data I have, I feel the spec set as 1000ppm is more reasonable based on the safety data of this solvent.