Low-Substituted Hydroxypropyl Cellulose

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 17-Nov-2023 (Item had an incorrect original posting date of September 26, 2023, and was corrected to November 17, 2023) 

Official Date: 01-Aug-2024

Expert Committee: Complex Excipients

Coordinating Pharmacopeia: United States Pharmacopeia

A revision to the harmonized standard for Low-Substituted Hydroxypropyl Cellulose has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 4 (former Stage 6) of the PDG process, the Low-Substituted Hydroxypropyl Cellulose monograph has been formally approved by the USP Complex Excipients Expert Committee in accordance with the Rules and Procedures of the 2020 – 2025 Council of Experts.

Changes from the existing monograph include:

  • Chemical Information
    • Corrected the CAS number from “9004-64-21” to “9004-64-2”.
  • Assay
    • Removed details of vial and heater block dimensions so that any suitable apparatus can be used.

Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Low-Substituted Hydroxypropyl Cellulose monograph will be incorporated into and become official with the USP-NF 2024 Issue 2 (August 1, 2024).

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