limit for n,n-dimethyl anilene
Posted: Tue Jun 04, 2013 8:32 am
by dhanireddy1982
Hi,
Kindly any one can tell me what is the limit for n,n- dimethyl anilene as aresidual solvent in drug substances.
Thanks
Re: limit for n,n-dimethyl anilene
Posted: Mon Jun 10, 2013 9:34 pm
by krickos
Hi
It is traditionally NOT treated as an residual solvent rather a specified impurity. Closely related to position isomers of dimethylaniline and O-toludine, with historical low limits (10-100ppm).
Not working with antibiotics anymore but n,n- dimethyl aniline was noy an uncommon part of the processes. Seen limits at down to 20ppm, a look into monographs for your drug substance or similar monographs may give a hint.