The Food and Drug Administration (FDA or Agency) is announcing the availability of recommendations for a new permitted daily exposure (PDE) for the residual solvent triethylamine and a revised PDE for the residual solvent methylisobutylketone. The PDEs were developed according to the methods for establishing exposure limits included in the guidance for industry entitled ``Q3C Impurities: Residual Solvents.'' The recommendations were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The document is intended to recommend acceptable amounts for the listed residual solvents in pharmaceuticals for the safety of the patient.
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Recommendations for the Permitted Daily Exposures for Two Solvents, Triethylamine and Methylisobutylketone, According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Council for Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of recommendations for a new permitted daily exposure (PDE) for the residual solvent triethylamin...
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82 FR 34537
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“Recommendations for the Permitted Daily Exposures for Two Solvents, Triethylamine and Methylisobutylketone, According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Council for Harmonisation; Guidance for Industry; Availability,” thefederalregister.org (July 25, 2017), https://thefederalregister.org/documents/2017-15537/recommendations-for-the-permitted-daily-exposures-for-two-solvents-triethylamine-and-methylisobutylketone-according-to-t.