Transcription of Annexes to: CPMP/ICH/283/95 Impurities: Guideline for ...
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Annexes to: CPMP/ICH/283/95 Impurities: Guideline for ...
20 February 2013 CPMP/QWP/450/03 - , EMEA/CVMP/511/03 Committee for medicinal products for human use (CHMP) Committee for medicinal products for veterinary use (CVMP) Annexes to: CPMP/ICH/283/95 impurities : Guideline for residual solvents & CVMP/VICH/502/99 Guideline on impurities : residual solvents Annex I: specifications for class 1 and class 2 residual solvents in active substances Annex II: residues of solvents used in the manufacture of finished products Discussion at Quality Working Party January 2003 to June 2004 Adoption by CVMP July 2004 Adoption by CHMP July 2004 Date for coming into operation January 2005 Rev. 01 Adoption by Quality Working Party 22 November 2012 Rev. 01 Adoption by CVMP 7 February 2013 Rev. 01 Adoption by CHMP 11 February 2013 Rev. 01 Date for coming into operation 1 March 2013 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Website European Medicines Agency, 2013.
solvents in active substances . Specifications for class 1 solvents In both the ICH and VICH guidelines on impurities: residual solvents it is stated that “ solvents in class 1 should not be employed in the manufacture of drug/active substances, excipients, and
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