VICH Residual Solvents Guidance

FDA has published a Veterinary International Conference on Harmonization guidance, Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2), that recommends acceptable amounts of residual solvents in pharmaceuticals for the safety of the target animal and for the safety of residues in products derived from treated food-producing animals. The document recommends using less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.

The guidance does not address solvents deliberately used as excipients and does not address solvates. “However, the content of solvents in such products should be evaluated and justified,” it says.

The document includes an Introduction, Scope of the Guidance, General Principles, Limits of Residual Solvents, Glossary, and three appendices.