Sucrose

Type of Posting: 
Notice of Adoption of Harmonized Standard
Expert Committee: 
Monographs—Excipients

* This standard, which was originally scheduled to become official on 01–May–2012, has been indefinitely postponed. Read more from the Revision Bulletin and download the currently official monograph.

Original Posting

A harmonized standard for Sucrose 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 Sucrose 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:

  • Replaced tests for chloride, sulfate, calcium, Residue on Ignition, and Heavy Metals with the Conductivity test.
  • Added tests for Sulfite, Appearance of Solution, Loss on Drying, and Color Value at the request of EP and in accordance with methods that are standards in the sugar industry and approved by the International Commission for Uniform methods in Sugar Analysis.
  • Replaced test for Invert Sugar with the test for Reducing Sugars.
  • Added test for Dextrins and Bacterial Endotoxins for preparation of large-volume infusions.
  • Added labeling requirement to state where applicable if the substance is suitable for large-volume parenteral dosage forms.

The Sucrose monograph will be incorporated into and become official with USP 35–NF 30.

Should you have any questions about the Sucrose monograph, please contact Kevin Moore (301-816-8369 or ktm@usp.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 mys@usp.org)