Methylcellulose

Please see the Compendial Notice CN-18-003 for the missing revision tag.

 

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 27–Apr–2018

Targeted Official Date: 01–May–2019

Expert Committee: Excipient Monographs 2

Coordinating Pharmacopoeia: Japanese Pharmacopoeia

The revision to the harmonized standard for Methylcellulose 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 Methylcellulose 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 Methylcellulose monograph include:

  • Assay
    • In the Sample solution preparation procedure, change from “If the weight loss is less than 0.5% of the contents and …” to “If the weight loss is less than 26 mg and …” 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 Methylcellulose monograph will be incorporated into and become official with USP 42–NF 37.

Should you have any questions about the Methylcelluose 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).