Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 27–Sep–2013; updated 28–Mar–2014
Official Date: 01–Aug–2014
Expert Committee: Monographs—Excipients
Coordinating Pharmacopeia: EP
A revision to the harmonized standard for Sucrose 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 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.
This harmonized standard, which was indefinitely postponed on March 30, 2012, has been updated to include the following revisions:
- The acceptance criteria of Color Value has been changed from “NMT 45” to “NMT 45 if labeled as parenteral grade; NMT 75 for non-parenteral grade,” based on comments received from stakeholders.
- A footnote has been added to the test for Sulfite: “Test kit for sulfite determination may be ordered from Boehringer Mannheim Roche/R-Biopharm, Catalog # 10 725 854 035.”
- The monograph has been edited to be consistent with the current USP style guide.
In addition, the original posting of the harmonized Sucrose monograph includes the following changes from the existing USP–NF monograph:
- 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.
- OPTICAL ROTATION: As part of the original Stage 6 posting on April 29, 2011, the acceptance criterion was revised from “NLT +65.9” to “+66.3 to +67.0.” Subsequently, an erratum was published on May 1, 2012 to specify the temperature required for the measurement. This erratum corrected the acceptance criteria to read “+66.3 to +67.0 at 20º.” However, the entire harmonized monograph was postponed on March 30, 2012, based on stakeholder comment to the Color Value specification which had to be clarified with the Pharmacopeial Discussion Group. These issues have been resolved, and the erratum was included in the Stage 6 Harmonized posting on September 27, 2013.
All the above changes to the current official USP–NF monograph will be implemented as part of this harmonized revision.
The Sucrose monograph will be incorporated into and become official with the First Supplement to USP 37–NF 32.
Should you have any questions about the Sucrose monograph, please contact Kevin Moore (301-816-8369 or email@example.com). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Emily Meyer (301-230-7438 or firstname.lastname@example.org).