A harmonized standard for Cellacefate has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Cellacefate monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.
Changes from the existing USP–NF monograph include:
- For Content of Acetyl, the statement requiring 5 drops of Phenolphthalein TS was removed.
- For Water Determination, the sample size of 0.5 g was added.
- Black diamond notation was added for non-harmonized attributes for the following: Heavy Metals, Packaging and Storage, USP Reference Standards.
The Cellacefate monograph will be incorporated into and become official with the Second Supplement to USP 35–NF 30.
Should you have any questions about the Cellacefate monograph, please contact Kevin Moore (301-816-8369 or firstname.lastname@example.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Mario Sindaco (301-816-8246 or email@example.com).
*The PDF that originally posted with this Notice of Adoption contained an official date of 01–Aug–2012. The date has been corrected to 01–Dec–2012.