limit for n,n-dimethyl anilene

[dhanireddy1982]

Hi,

Kindly any one can tell me what is the limit for n,n- dimethyl anilene as aresidual solvent in drug substances.


Thanks

[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.