VICH GL18(R2) Impurities: residual solvents in new veterinary medicinal products, active substances, and excipients
Residual solvents are unavoidable components in pharmaceutical production and will often be part of veterinary medicines. The target is to limit the amount of residual solvents in pharmaceutical products for the safety of the animal, as well as for the safety of residues in products derived from treated food-producing animals. They should not exceed the recommended levels except in exceptional circumstances, in which case they must be justified.
The new version (R2) of residual solvents in veterinary drugs has been aligned with the ICH Q3C guideline (R8) applicable to products for human use in terms of changes in the classification of some solvents and the inclusion of new ones.
Two solvents with low toxic potential (class 3) have been reclassified as class 2 solvents (solvents to be limited):
- Cumene
- Methylisobutylketone.
Other solvents have been added new to the classification:
- Cyclopentyl methyl ether and tert-butanol in class 2,
- Triethylamine, in class 3.
As in the previous version, a difference with the regulation for products for human use is still maintained, since an additional option for the description of class 2 solvent limits, option 3, is envisaged. In this option, the possibility of justifying higher PDE levels and concentration limits based on the actual daily dose, the actual target species (body weight), and relevant toxicological data are considered. The use of this option will be evaluated on a case-by-case basis by the Authorities.
This new revision will come into force in April 2024.
