Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 20–Nov–2015

Official Date: 01–Dec–2016

Expert Committee: Excipient Monographs 2

Coordinating Pharmacopeia: Japanese Pharmacopoeia

The correction to the harmonized standard for Hypromellose 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 Hypromellose monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.

The changes from the previous Stage 6 posting on November 21, 2014 include:

  • Viscosity
    • Added the temperature range of “(90 – 99 0)” for clarification of hot water used for dissolution of the sample in both Method 1 and Method 2, based on the information provided by sponsor.
  • Assay
    • In sample solution preparation, deleted “dried” from 0.065 g of Hypromellose. The as-is sample could be used for sample solution preparation, but the Assay needs to be calculated based on the dried basis according to the Loss on Drying result.

Additionally, the monograph has been edited to be consistent with the current USP style.

The Hypromellose monograph will be incorporated into and become official with the Second Supplement to USP 39–NF 34.

Should you have any questions about the Hypromellose monograph, please contact Tong (Jenny) Liu (240-221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or rll@usp.org).