Polysorbate 80

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 24–Apr–2015; updated 29–Apr–2015*

Official Date: 01–May–2016

Expert Committee: Monographs—Excipients

Coordinating Pharmacopoeia: European Pharmacopoeia

A revision to the harmonized standard for Polysorbate 80 has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Corr. 2 Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Polysorbate 80 monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

On April 1, 2015 USP revised General Notices: Section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements via a Revision Bulletin which established January 1, 2018 as the new date of applicability of General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Dietary Supplements. This new date is intended to align the implementation of General Chapter <232> more closely with that of the ICH Q3D Guideline for Elemental Impurities. The implementation of General Chapters <232> and <2232> will coincide with the removal of all references to General Chapter <231> Heavy Metals from monographs and General Chapters in the USP–NF. Accordingly, the reference to General Chapter <231> Heavy Metals in this monograph is omitted with an official implementation date of January 1, 2018, as indicated in the recently revised General Notices. For further details see General Chapter <231> Heavy Metals and Affected Monographs and General Chapters Revision Bulletin.

Changes from the existing USP–NF monograph include:

  • Assay
    • Added a Description for the “Boron trifluoride–methanol solution” and changed the text accordingly in the Sample solution.. 
  • Heavy Metals
    • Deleted the Heavy Metals test. The official implementation date for this revision is January 1, 2018. 
  • Fats and Fixed Oils, Acid Value <401>
    • Changed from “hexane” to “light petroleum” in the mixture with alcohol for the solvent according to the PDG Stage 6 sign-off document.  The properties of light petroleum and the suitable reagent have been described also.
  • Added the symbols   to the non-harmonized attribute Identification B. Infrared Absorption

Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Polysorbate 80 monograph will be incorporated into and become official in USP 39–NF 34. 

Should you have any questions about the Polysorbate 80 monograph, please contact Kevin Moore (301-816-8369 or ktm@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization website or contact Emily Meyer (301-230-7438 or eam@usp.org).

*The Polysorbate 80 monograph that was posted on April 24, 2015 had an incorrect official date of May 1, 2015, instead of May 1, 2016. A corrected version of the PDF was posted on April 29, 2015.