Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 29–Apr–2011
Official Date: 01–May–2012
Expert Committee: Monographs—Excipients
A 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 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.
Changes from the existing USP–NF monograph include:
- Indicated three separate grades of Stearic Acid in the Definition based on composition of Stearic and Palmitic Acids.
- Added Freezing Point, Acid Value, and Retention time from the Assay as Identification tests.
- Replaced packed column GC with capillary column GC method for the Assay.
- Updated Iodine Value specifications depending on grade of Stearic Acid.
- Added new tests Color of Solution and Acidity at the request of EP.
- Added Labeling requirement to state the type of Stearic acid.
The Stearic Acid monograph will be incorporated into and become official with USP 35–NF 30.
Should you have any questions about the Stearic Acid monograph, please contact Kevin Moore (301-816-8369 or firstname.lastname@example.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Mario Sindaco (301-816-8246 or email@example.com).