Hypromellose Phthalate

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 27–Apr–2018

Official Date: 01–May–2019

Expert Committee: Excipient Monographs 2

Coordinating Pharmacopeia: Japanese Pharmacopoeia

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

Changes from the current Hypromellose Phthalate monograph include as below:

  • In the beginning of the monograph
    • Added the statement: “Portions of this monograph that are national USP text, and are not part of the harmonized text, are marked with symbols dotdot.jpg to specify this fact.”
  •  Identification (ID)
    • Added the symbols dotdot.jpg , because it is a non-harmonized attribute.
  • Chloride 
    • Added a description for Analysis by specifying the detailed procedure.
  • Limit of Free Phthalic Acid
    • Corrected the mobile phase to “0.1% Trifluoroacetic acid and Acetonitrile (90:10)” from “Acetonitrile and 0.1 M cyanoacetic acid (15:85)”, according to the PDG sign-off document. 
    • Clarified that both standard and sample are weighed accurately, then transferred to volumetric flask. 
  • Labeling
    • Added the symbols dotdot.jpg , because it is a non-harmonized attribute.

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

The Hypromellose Phthalate monograph will be incorporated into and become official with the USP 42–NF 37.

Should you have any questions about the Hypromellose Phthalate 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 Group or contact Richard Lew at (240-221-2060 or rll@usp.org).