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 Hypromellose 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 Hypromellose 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, the column has been corrected to state the packing phase as G1 instead of G28 to be consistent with signed off harmonized text.
- For the Heavy Metals test, a deviation from Method III is added to be consistent with the signed off harmonized text.
- For the pH test, eliminated the temperature requirement as the information is redundant from the Viscosity measurement.
- 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.
- Packaging and Storage is labeled as USP national text.
The Hypromellose 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)