Polysorbate 80

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 30–Sep–2016

Official Date: 01–Aug–2017

Expert Committee: Excipient Monographs 2

Coordinating Pharmacopoeia: European Pharmacopoeia

The revision to the harmonized standard for Polysorbate 80 has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 6 of the PDG process, the Polysorbate 80 monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.

Changes from the existing ;USP–NF monograph include:

  • Composition of Fatty Acids
    • Added “Injection type: Split ratio, 50:1” in the gas chromatographic condition, because split ratio has significant impact on the resolution for meeting the system suitability requirements.
  • Ethylene Oxide and Dioxane
    • Added the conversion factor of 1000 to the calculation formula for Dioxane in order to get the content of Dioxane in units of ppm.
    • Clarified that the calculation result for Ethylene Oxide is in units of ppm.
  • Additionally, the monograph has been edited to be consistent with the current USP style.

The Polysorbate 80 monograph will be incorporated into and become official with the First Supplement to USP 40–NF 35.

Should you have any questions about the Polysorbate 80 monograph, please contact Tong (Jenny) Liu (240-221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or rll@usp.org).