GUIDANCE DOCUMENT

ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents July 2017

Final

Docket Number:: FDA-2010-N-0327 (Cumene) FDA-2015-D-3474 (Triethylamine/Methylisobutylketone) 4 Guidances listed under this Document:Triethylamine/Methylisobutylketone - pdf on web Tetrahydrofuran (THF) - pdf ON web; Docket #2001B-0431 N-Methylpyrrolidone (NMP) - pdf ON
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

The International Council on Harmonisation (ICH) has developed maintenance procedures (PDF - 26KB) for revising the permitted daily exposure (PDE) of solvents included in the Q3C guidance

This web page makes available to the public all recommendations, decisions, and other information related to the revision of the Q3C tables and list (PDF - 183KB).

Draft Recommendations for New PDEs
- 2-Methyltetrahydrofuran
  - ICH Step 2 recommendation: Impurities: Residual Solvents (Maintenance) PDE for 2-Methyletrahydrofuran (PDF-134KB), Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol,—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Conference on Harmonization; Availability
- Cyclopentyl Methyl Ether
  - ICH Step 2 recommendation: Impurities: Residual Solvents (Maintenance) PDE for Cyclopentyl Methyl Ether (PDF- 134KB), Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol,—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Conference on Harmonization; Draft Guidance for Industry; Availability
- Tert-Butyl Alcohol
  - ICH Step 2 recommendation: Impurities: Residual Solvents (Maintenance) PDE for Tert-Butyl Alcohol (PDF- 134KB), Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol,—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Conference on Harmonization; Availability
Final Recommendations for Revision to the List
- Triethylamine and Methylisobutylketone
  - ICH Step 2 recommendation for revision: Impurities: Residual Solvents (Maintenance) PDE for Triethylamine (PDF - 87KB) Draft Recommendations for the Revision of the Permitted Daily Exposures (PDE) for Two Solvents, Triethylamine and Methylisobutylketone, According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Conference on Harmonization;
- Tetrahydrofuran (THF)
  - ICH Step 4 recommendation for revision: Impurities: Residual Solvents (Maintenance) PDE for Tetrahydrofuran (PDF - 67KB) International Conference on Harmonisation; Final 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. (FR 68(219):64352 - 11/13/2003)
- N-Methylpyrrolidone (NMP)
  - ICH Step 4 recommendation for revision: Impurities: Residual Solvents (Maintenance) PDE for N-Methylpyrrolidone (NMP) (PDF - 69KB) International Conference on Harmonisation; Final 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. (FR 68(219):64352 - 11/13/2003)
- Cumene
  - ICH Step 4 recommendation for revision: Impurities: Residual Solvents (Maintenance) PDE for Cumene (PDF - 119KB) International Conference on Harmonization: Final Recommendations for the Revision of the Permitted Daily Exposures (PDE) for Cumene, According to the Maintenance Procedures for Q3C Impurities: Residual Solvents; Availability. (FR 77(36): 10754 - 2/23/2012)

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All written comments should be identified with this document's docket number: FDA-2010-N-0327 (Cumene) FDA-2015-D-3474 (Triethylamine/Methylisobutylketone) 4 Guidances listed under this Document:Triethylamine/Methylisobutylketone - pdf on web Tetrahydrofuran (THF) - pdf ON web; Docket #2001B-0431 N-Methylpyrrolidone (NMP) - pdf ON.