Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 26–Apr–2013; updated 26–Jul–2013
Official Date: 01–May–2014
Expert Committee: Monographs—Excipients
A harmonized standard for Methylcellulose 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 Methylcellulose 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 Assay procedure, text has been added in a note to “use a column giving well resolved peaks of methyl iodide and the internal standard in that order."
- For the Viscosity test under the section of Operation of apparatus, detailed wording allowing a rest period of “at least” 2 minutes between measurements was added.
- For the pH test, eliminated the temperature requirement as the information is redundant from the Viscosity measurement.
The Methylcellulose monograph will be incorporated into and become official with USP 37–NF32.
Should you have any questions 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).