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

Current effective version

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)

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

AdoptedReference Number: EMA/CVMP/VICH/502/1999

Document history

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

AdoptedReference Number: EMA/CVMP/VICH/502/1999

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

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

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

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

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

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

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

Consultation dates: 20/05/2010 to 31/10/2010Draft: consultation closedReference 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Application of VICH GL 18 on residual solvents to veterinary medicinal products containing existing active substances - Superseded

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

VICH GL18: Impurities: Residual solvents - Step 7

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