Ethanol, 2-(2-ethoxyethoxy)-;
2-(2-Ethoxyethoxy)ethanol [111-90-0]
BRIEFING
Diethylene Glycol Monoethyl Ether. This proposal is based on the version of the monograph official as of May 1, 2020. On the basis of comments and data received and to align with the corresponding European Pharmacopoeia 11.0 monograph, it is proposed to make the following revisions:
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In the Chemical Information section of the monograph, update the molecular weight of diethylene glycol monoethyl ether and add two chemical names and a Chemical Abstracts Service (CAS) number.
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In the Labeling section, remove the requirement that this excipient is intended for topical or transdermal use only and is not to be used for parenterals. Data provided by the sponsor of this revision support the use of this excipient by other routes of administration.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SE: G. Holloway)
Correspondence Number—C325815