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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance provides recommendations for permitted daily exposures (PDEs) for three additional residual solvents: (1) 2-methyltetrahydrofuran, (2) cyclopentyl methyl ether, and (3) tert-butyl alcohol. This guidance is intended to recommend acceptable amounts for these residual solvents in pharmaceuticals for the safety of the patient. As part of the maintenance process for the ICH guidance for industry Q3C Impurities: Residual Solvents (December 1997), the Q3C PDE levels are added and revised as new toxicological data for solvents become available.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2020-D-1301.