VICH GL18(R2) impurities: residual solvents in new veterinary medicinal products, active substances and excipients - Scientific guideline

This document recommends 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. Read together with the annexes on specifications for class 1 and class 2 residual solvents in active substances and residues of solvents used in the manufacture of finished products.

Keywords: Organic solvent, impurity, limits, class, reporting levels, exposure limits, VICH, veterinary medicinal product (VMP)