International Activities

The International Conference on Harmonisation (ICH) has developed maintenance procedures for revising the permitted daily exposure (PDE) of solvents included in the guidance for industry Q3C Impurities: Residual Solvents. A list of these solvents was included in the guidance, but is now a companion guidance called Q3C Tables and List [Word] or [PDF]  (Posted 11/12/2003)
 

This web page makes available to the public all recommendations, decisions, and other information related to the revision of the tables and list.

• Proposal for Q3C Impurities:  Residual Solvents Type of Maintenance:  Updating Based on New Information

• Tetrahydrofuran (THF)
  • ICH Step 2 draft recommendation for revision: Impurities: Residual Solvents (Maintenance) PDE for Tetrahydrofuran.  Optional format:  PDF  (Issued 7/20/2000, Posted 8/29/2001)
  • International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures (PDE) for Two Solvents, N-Methylpyrrolidone and Tetrahydrofuran, According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; Availability. [TXT] [PDF]  (Posted 2/11/2002)
• N-Methylpyrrolidone (NMP)
  • ICH Step 2 draft recommendation for revision: Impurities: Residual Solvents (Maintenance) PDE for N-Methylpyrrolidone (NMP). Optional format:  PDF  (Issued 7/20/2000, Posted 8/29/2001)
  • International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures (PDE) for Two Solvents, N-Methylpyrrolidone and Tetrahydrofuran, According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; Availability.  [TXT] [PDF]   (Posted 2/11/2002)