Polysorbate 80

Type of Posting: 
Revision Bulletin
Posting Date: 
30–Jul–2010; updated 11–Aug–2010* and 28–Jan–2011**
Official Date: 
01–Oct–2010
Expert Committee: 
Monographs—Excipients

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs Excipients Expert Committee has revised the Polysorbate 80 monograph. The purpose for the revision is to correctly reflect the intent of the Pharmacopeial Harmonization Group (PDG) harmonized text, which was signed off in October 2009. Tests for Viscosity and Specific Gravity fall under the "Characters" section of the PDG sign-off text and are non-harmonized attributes, and the text has been revised to reflect the current official USP text for Polysorbate 80. Characters have been agreed upon by PDG as being non-harmonized attributes, and therefore, have been removed from the table containing Harmonized Attributes.   The Characters section is not a part of the official USP monograph.

For Residue on Ignition, reference to the General Chapter <281> Residue on Ignition was removed as the complete procedure is listed in the revised monograph.  Finally, a correction was made to the chromatographic tables for the tests for Composition of Fatty Acids and Ethylene Oxide and Dioxane to align with the PDG sign-off text.

The Polysorbate 80 Revision Bulletin supersedes the Polysorbate 80 monograph from the USP 33–NF 28 Reissue which was scheduled to be official on 01 October 2010.   The Revision Bulletin will be incorporated into the First Supplement to USP 34–NF 29.

Should you have any questions, please contact Dr. Kevin Moore (301-816-8369 or ktm@usp.org).

*The posting on 11 August 2010 replaced the 30 July 2010 posting. The 11 August 2010 posting revised the official date to October 1, 2010 to align with other monograph changes coming official October 1, 2010 in the USP 33-NF 28 Reissue and to correct the units for the chromatographic column dimensions in the composition of fatty acids test and the test for ethylene oxide and dioxane which were incorrect in the 30 July 2010 posting only. This explanation was posted 15 October 2010.

** This posting on 28 January 2011 replaces the 11 August 2010 posting; only the 28 January 2011 posting is available. The posting on 28 January 2011 revises the official publication in which this Revision Bulletin will appear to the First Supplement to USP 34–NF 29. There is no change to the official text. This explanation was posted 28 January 2011.