By patri on Tuesday, April 27, 2004 - 08:37 am:
what concentration should be prepared for residual solvents in drug substance by gc?
By Carlos Teixeira on Tuesday, April 27, 2004 - 09:30 am:
Hello Patri,
You can use the limit of your residual solvents. Exemple, if you have to analize Toluene, you can use 860ppm, because it is the limit of
Toluene in pharmaceutical product (API, excipients or final product). You can see about it in Eur. Pharmacop. 4th Edition our in ICH Guideline "Residual Solvents". They present one list with several solvents and its limits.
Bye