Ethylcellulose

Type of Posting: 
Notice of Adoption of Harmonized Standard
Posting Date: 
30–Nov–2012
Official Date: 
01–Dec–2013
Expert Committee: 
Monographs—Excipients

A harmonized standard for Ethylcellulose 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 Ethylcellulose 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:

  • Updated concentration of the ferric chloride sulfamic acid reagent in the Acetaldehydes test to 16 mg/mL. Revised solvent used for preparation of the acetaldehyde standard solution to water from 2-Propanol.
  • Revised reagent reference for Chlorides test to Nitric Acid, Diluted, from specific preparation used in Solution A.
  • Specified 1 g of sample size for Loss on Drying

Should you have any questions about the Ethylcellulose 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 Web page or contact Mario Sindaco (301-816-8246 or mys@usp.org).