Sub menu

 
 

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 manufacture of finished products

We have adopted this International Scientific Guideline - CPMP/QWP/450/03 - Rev.1, EMEA/CVMP/511/03 - Rev.1.

Last updated

About this guideline

Overseas effective date: 1 March 2013

Categories: Quality | Impurities

Replaces: CPMP/QWP/450/03, EMEA/CVMP/511/03 (Adopted by TGA 13 January 2005)

TGA annotations: Nil

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

Help us improve the Therapeutic Goods Administration site