Stearic Acid

Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 30-Sep-2022
Official Date: 01-Aug-2023
Expert Committee: Complex Excipients
Coordinating Pharmacopeia: European Pharmacopeia

A revision to the harmonized standard for Stearic Acid has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 4 of the PDG process, the Stearic Acid monograph has been formally approved by the USP Complex Excipients Expert Committee in accordance with the Rules and Procedures of the 2020–2025 Council of Experts.

Changes from the existing USP–NF monograph include:

  1. Freezing Point  
    • Added an alternative procedure based on an equivalency study performed by PDG. In addition, a note was added: "Note—The following two procedures are equivalent and interchangeable. Only one procedure needs to be performed.”
  2. Definition, Identification A, Identification B, Identification C, Assay, Acidity, Iodine Value, and Labeling (type of Stearic Acid). No changes for these harmonized attributes.
  3. Residue on Ignition, Color of Solution, Packaging and Storage, and Labeling (external use). No changes from the existing USP–NF text.
  • Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Stearic Acid monograph will be incorporated into and become official with the USP-NF 2023 Issue 2 (August 1, 2023).

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

The previous PDG sign-off Cover Pages and Stage 4 postings are included as below: