Cellulose Acetate

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 30–Sep–2016 (updated 26-Feb-2017*)

Targeted Official Date: 01–Aug–2017

Expert Committee: Excipient Monographs 2

Coordinating Pharmacopoeia: United States Pharmacopoeia

The revision to the harmonized standard for Cellulose Acetate 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 Cellulose Acetate 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 existing USP–NF monograph include:

  • Identification (ID)
    • The sample preparation is revised to use acetone to dissolve mono- and di-esters and methylene chloride to dissolve di- and tri-esters in order to resolve the solubility issue. Hence, the revised monograph states “Sample solution: Prepare a 20 mg/mL solution of Cellulose Acetate, previously dried, in acetone (mono- and diester) or in methylene chloride (di- and triester).”
  • Additionally, the monograph has been edited to be consistent with the current USP style.

The Cellulose Acetate monograph will be incorporated into and become official with the First Supplement to USP 40–NF 35.

Should you have any questions about the Cellulose Acetate 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).