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

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

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

AdoptedReference Number: EMA/CVMP/VICH/502/99-Rev.1Legal 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

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

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

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of VICH GL 18 on residual solvents to veterinary medicinal products containing existing active substances - Superseded

AdoptedReference Number: EMEA/CVMP/423/01-FINALLegal effective date: 01/05/2001

VICH GL18: Impurities: Residual solvents - Step 7

AdoptedReference Number: CVMP/VICH/502/99-FinalLegal effective date: 01/06/2001