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 revision 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 4 (former 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 current Hypromellose monograph include:

  • Assay
    • In the Sample solution preparation procedure, change from “If the weight loss is ≥0.5% of the contents or …” to “If the weight loss is ≥26 mg or …” based on the inability to calculate a percentage deviation from its contents. The weight loss is based on the mass of the contents, and not on the total mass of the apparatus, plus the contents.
    • In the GC analysis, replace the packed GC column with a capillary GC column. A suitable column is DB-1, 0.53-mm × 30-m, 3-µm of phase G1 from Agilent Technologies. The retention time for internal standard (n-octane) is about 10 min.

    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 USP 42–NF 37.

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).