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GUIDANCE DOCUMENT

PDEs for Triethylamine and for Methylisobutylketone July 2017

Download the Final Guidance Document Read the Federal Register Notice
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Triethylamine (TEA) is used as catalytic solvent in chemical synthesis (1,2). It is a colourless liquid that is soluble in water, ethanol, carbon tetrachloride, and ethyl ether, and very soluble in acetone, benzene, and chloroform. TEA has a vapour pressure of 54 mmHg (20°C), and has been reported to be irritating to the lung and nasal passage with strong ammoniac odour.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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