Hypromellose

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 21–Nov–2014

Targeted Official Date: 01–Dec–2015

Expert Committee: Monographs—Excipients

Coordinating Pharmacopoeia: Japanese Pharmacopoeia

The correction to harmonized standard for Hypromellose has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Corr. 1 sign-off cover sheet. 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.

On December 27, 2013, USP announced the approval of General Notices section 5.60.30 “Elemental Impurities in USP Drug Products and Dietary Supplements” with an official date of December 1, 2015. This General Notices section will make applicable General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Dietary Supplements. The implementation of General Chapters <232> and <2232> also will include removal of all references to General Chapter <231> Heavy Metals from monographs and General Chapters in the USP–NF. In order to fully implement the omission of <231>, the test of Heavy Metals in this monograph is deleted with the official date of December 1, 2015, according to the General Notices in USP38–NF33.

In order to be consistent with current USP style and the current General Notices 5.60.30, changes from the existing USP–NF monograph include:

  • Heavy Metals
    • Deleted the test according to section 5.60.30 in General Notices. The official date will be Dec. 1, 2015.
  • Viscosity
    • Updated the title of the Viscosity General Chapters to Viscosity—Capillary Methods <911> and Viscosity—Rotational Methods <912>. The official date for this revision is May 1, 2015.

For further details on the changes to the Viscosity General Chapters please see the compendial notice: Monographs and GC Affected by Revisions to GC <911>, <912>, and <913>. For an explanation of the new “CN” revision markup please see the New Revision Markup for Reference Changes in USP–NF compendial notice. These compendial notices and similar notices are posted under the Compendial Notices section of the USP Web site.

The Hypromellose monograph will be incorporated into and become official with the Second Supplement to USP 38–NF 33.

Should you have any questions about the Hypromellose 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).