Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 29–Sep–2017
Official Date: 01–Aug–2018
Expert Committee: Excipient Monographs 2
*Coordinating Pharmacopeia: European Pharmacopoeia
The revision to the harmonized standard for Ethylcellulose 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 Ethylcellulose 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:
- Added the statement of “It may contain a suitable antioxidant.”
- Changed from <197K> to <197F>. Added the sample preparation procedure.
- In line with the procedure described for the Assay in the harmonized standards of other cellulosics monographs, a revised procedure for determination of the assay using a capillary column is included. A suitable column is RTX-1, 0.53-mm × 30-m, 3-µm, G1 column from Restek, or DB-1 or HP-1 from Agilent Technologies.
- Added the statement of “The label states the name and amount of any added antioxidant.”
- USP Reference Standards
- Deleted the duplicate names according to USP style.
- Additionally, the monograph has been edited to be consistent with the current USP style.
The Ethylcellulose monograph will be incorporated into and become official with the First Supplement to USP 41–NF 36.
*Should you have any questions about the Ethylcellulose monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or firstname.lastname@example.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 email@example.com).
*The previous PDG sign-off Cover Pages and Stage 6 postings are included as below:
- Download the Ethylcellulose Monograph – Stage 6
- Download the Ethylcellulose PDG sign-off document:
- Previous Stage 6 web posting (posted 30–Nov–2012; official 01–Dec–2013
- Previous Stage 6 posting in PF 30 (2), 2004
- Previous Stage 6 posting in PF 28 (5), 2002