Guidance for Industry. Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision)

摘要

The objective of this guidance is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the target animal as well as for the safety of residues in products derived from treated food producing animals. The guidance recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.