Stearic Acid

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: EP

A revision to the harmonized standard for Stearic Acid has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 1 Corr. 1 Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Stearic Acid 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:

  • Identification. B
    • Corrected the molecular weight of potassium hydroxide from “56.10” to “56.11” based on the rounded value.
  • Heavy Metals
  • Deleted the Heavy Metals test. The official implementation date for this revision is January 1, 2018.
  • Added the symbols to the following non-harmonized attributes or local requirements: Note to the Definition section, Color of Solution, and a part of the Labeling section.

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

Stearic Acid monograph will be incorporated into and become official in USP 39–NF 34. 

Should you have any questions about the Stearic Acid 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 Group or contact Emily Meyer (301-230-7438 or eam@usp.org).

The Stearic Acid 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.