DI ISOPROPYL ETHER ICH LIMIT
Posted: Fri Apr 01, 2011 10:00 am
Please tell me ICH limt for DI ISOPROPYL ETHER in API.
Hi
ICH Q guidelines can be found here:
http://www.ich.org/products/guidelines/ ... lines.html
If memory serves there is no set limit, belive your solvent belongs to the below class per ICH Q3C:
4.4 Solvents for which No Adequate Toxicological Data was Found
The following solvents (Table 4) may also be of interest to manufacturers of
excipients, drug substances, or drug products. However, no adequate toxicological
data on which to base a PDE was found. Manufacturers should supply justification for
residual levels of these solvents in pharmaceutical products.