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Simethicone Emulsion

Type of Posting: Notice of Intent to Revise

Posting Date: 27–Apr–2012

Targeted Official Date: Interim Revision Announcement, 01–Jan–2013

Expert Committee: Monographs—Small Molecules 3

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 3 Expert Committee intends to revise the Simethicone Emulsion monograph. The purpose of the revision is to address possible interference of the excipient matrix with the infrared absorption Identification test.

Comments were received that the presence of small amounts of organic emulsifiers in the toluene extract of Simethicone Emulsion may result in appearance of additional absorption bands in the spectrum obtained from the Sample solution, and may also cause a shift of the absorption band near 1085 cm-1 as compared to the spectrum obtained from the Standard solution. To address the comment, it is proposed to revise the Acceptance criteria and include the list of the characteristic polydimethylsiloxane bands to be present in the spectra.

It is anticipated that the revision will be published as a Proposed Interim Revision Announcement in PF 38(4) [Jul – Aug. 2012] pursuant to section 7.02 of the Rules and Procedures. Interested parties are encouraged to submit comments on the proposal.

Should you have questions, please contact Elena Gonikberg, Ph.D., Principal Scientific Liaison to the Monographs—Small Molecules 3 Expert Committee (301-816-8251 or