Guidelines ICH

• Q3C : Impurities: Residual Solvents
  Implementation (Step 5):
  EU : Adopted by CPMP, September 97, issued as CPMP/ICH/283/95
  MHLW: Adopted March 1998, PMSB/ELD Notification No.307
  FDA : Published in the Federal Register, Vol. 62, No. 247, December 24, 1997, page 67377
• Q3C (M) : Impurities : Residual Solvents (Maintenance)
                   PDE for N-Methylpyrrolidone (NMP)
  Two mistyping corrections in calculation formula have been given on October 28, 2002.
  Page 2 : for the first line, 99.3 for molecular weight was wrong. Correct value is 99.13
  and 608.16 mg/m³ = 0.608 mg/L (and not 608.16 mg/m³ = 608.16 mg/L as previously mentioned).
• Q3C (M) : Impurities : Residual Solvents (Maintenance)
                     PDE for Tetrahydrofuran
  Implementation (Step 5):
  EU: Adopted by CPMP, September 2002, issued as CPMP/ICH/1940/00
  MHLW: Adopted 25 December 2002, Notification ELD N° 1225006
  FDA: To be Notified

• Q3C : Impurities Residual Solvents - December 1997
• Q3C : Tables and List - December 1997
• Q3C: Appendix 4. Toxicological Data for Class 1 solvents (draft)
• Q3C: Appendix 5. Toxicological Data for Class 2 solvents (draft)
• Q3C: Appendix 6. Toxicological Data for Class 3 solvents (draft)

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Jean Cumps - Faculé de Médecine UCL - Ecole de Pharmacie - TPAO