August 2011
EMA/CHMP/ICH/82260/2006
ICH
guideline Q3C (R5) on impurities: guideline for
residual
solvents
Step 5
Part I (Parent guideline)
Transmission to CHMP
November 1996
Adoption by CHMP for release for consultation
November 1996
End of consultation (deadline for comments)
May 1997
Final
adoption by CHMP
September 1997
Date for coming into
effect
March 1998
Part II and part III (PDE for Tetrahydrofuran and N-Methylpyrrolidone)
Transmission to CHMP
July 2000
Adoption by CHMP for release for consultation
July 2000
End of consultation (deadline for comments)
September 2000
Final
adoption by CHMP
September 2002
Corrigendum to
calculation formula for NMP
November 2002
Transmission to CHMP
March 2003
Update of table 2, table 3 and appendix 1
to reflect the
revision of the PDEs for N-Methylpyrrolidone and
Tetrahydrofuran Q3C(R4)
February 2009
Part IV (PDE for cumene)
Transmission to CHMP
June 2010
Adoption by CHMP for release for consultation
June 2010
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
ich@ema.europa.eu
Website
www.ema.europa.eu
© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
