Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 27–Sep–2013
Official Date: 01–Aug–2014
Expert Committee: Monographs—Excipients
A revision to the harmonized standard for Cellulose Acetate 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 Cellulose Acetate 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:
- For Infrared Absorption sample solution, defined the sample concentration as 20mg/mL and change solvent from "Dioxane" to "Acetone.”
- For Limit of Free Acid, added the requirement to wash the flask and the filter with “freshly boiled and cooled” water.
- Added the requirements for Microbial Enumeration Tests and Tests for Specified Microorganisms.
In addition, the monograph has been edited to be consistent with the current USP style guide.
The Cellulose Acetate monograph will be incorporated into and become official with the First Supplement to USP 37–NF 32.
Should you have any questions about the Cellulose Acetate 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).