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

This guideline 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 Annexes to CPMP/ICH/283/95 impurities: Guideline for residual solvents and CVMP/VICH/502/99 guideline on impurities: Residual solvents - Revision 1

Note that the annexes are under consultation, see below under 'Document history'.

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

Current effective version

VICH GL18(R2) impurities: residual solvents in new veterinary medicinal products, active substances and excipients - Revision 2

Adopted Reference Number: EMA/CVMP/VICH/502/1999

Document history

Annexes to ICH Q3C guideline on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006) and VICH GL18 Impurities: residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/1999) - Revision 2

Draft: consultation open Consultation dates: 29/04/2026 to 30/06/2026 Reference Number: CPMP/QWP/450/03 Rev.2; EMEA/CVMP/511/03 Rev.2 Summary:

Only Annex I has been updated. Comments are requested on the updates implemented to Annex I and on the helpfulness of the decision trees (new addition). Annex II has not been revised, hence no comments are expected on this section.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

VICH GL18(R2) impurities: residual solvents in new veterinary medicinal products, active substances and excipients - Revision 2

Adopted Reference Number: EMA/CVMP/VICH/502/1999

Draft VICH GL18 (R2) Impurities: residual solvents in new veterinary medicinal products, active substances and excipients - Revision 2

Draft: consultation closed Consultation dates: 31/01/2022 to 10/06/2022 Reference Number: EMA/CVMP/VICH/502/1999

VICH GL18(R): Impurities: Residual solvents in new veterinary medicinal products, active substances and excipients - Revision 1

Adopted Reference Number: EMA/CVMP/VICH/502/99-Rev.1 Legal effective date: 01/07/2012

Annexes to CPMP/ICH/283/95 impurities: Guideline for residual solvents andCVMP/VICH/502/99 guideline on impurities: Residual solvents - Revision 1

Adopted Reference Number: CPMP/QWP/450/03 Rev.1 Legal effective date: 01/03/2013

Draft VICH GL 18 residual solvents in new veterinary medicinal products, active substances and excipients - Revision 1

Draft: consultation closed Consultation dates: 20/05/2010 to 31/10/2010 Reference Number: EMA/CVMP/VICH/502/1999-Rev.1

Application of VICH GL 18 on residual solvents to veterinary medicinal products containing existing active substances - Superseded

Adopted Reference Number: EMEA/CVMP/423/01-FINAL Legal effective date: 01/05/2001

VICH GL18: Impurities: Residual solvents - Step 7

Adopted Reference Number: CVMP/VICH/502/99-Final Legal effective date: 01/06/2001