Type of Posting: Notice of Intent to Revise
Posting Date: 26-Feb-2021; updated 02–Apr–2021; updated 18-Jun-2021*
Targeted Official Date: TBD
Expert Committee: Simple Excipients
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Simple Excipients Expert Committee intends to revise the USP Sucrose monograph.
Comments were received that the test kit for performing the Sulfite test that is referenced in a footnote in the monograph is no longer available. The current Sulfite test states “Determine the sulfite content by a suitable enzymatic method …” (emphasis added) with a footnote that states “Test kit for sulfite determination may be ordered from Boehringer Mannheim Roche/R-Biopharm, Catalog #10 725 854 035.” (emphasis added).
Since the Sucrose monograph is part of the work plan of Pharmacopeial Discussion Group (PDG), USP has informed PDG about the discontinuation of the current test kit. The European Pharmacopeia (Ph. Eur.), as the coordinating pharmacopeia of this monograph, is currently leading the effort to evaluate alternative test kits and has shared some evaluation results with PDG.
USP Simple Excipients Expert Committee reviewed the evaluation results completed by the Ph. Eur. experts for Megazyme’s test kit and agreed that the test kit is a suitable replacement for the sulfite test kit currently referenced in the Sucrose monograph. The Simple Excipients Expert Committee proposes to update the footnote of the USP Sucrose monograph through an accelerated revision process and include the following reference:
- Megazyme/Neogen: https://www.megazyme.com/total-sulfite-assay-kit-enzymatic
The following two test kits are currently still under evaluation:
- Nzytech: https://www.nzytech.com/products-services/analytical-products/analytical-test-kits/ak00071/
- r-Biopharm replacement test kit: https://food.r-biopharm.com/products/enzytec-generic-sulfite-so2-total/
According to USP General Notices 6.80.20. Instrumental Apparatus, “Where a particular brand or source of a material, instrument, or piece of equipment, or the name and address of a manufacturer or distributor, is mentioned (ordinarily in a footnote), this identification is furnished solely for informational purposes as a matter of convenience, without implication of approval, endorsement, or certification.” Therefore, stakeholders can determine sulfite content using any suitable enzymatic method and utilize any suitable test kit.
Additionally, PDG is aware that there may be other test kits on the market. However, due to limited time and resources, PDG currently cannot evaluate all of them. If stakeholders have evaluated any other test kits and obtained results comparable to the existing test kit in the compendial monograph footnote, please do not hesitate to contact USP, European Pharmacopeia, or Japanese Pharmacopeia, with your supporting data.
Should you have any questions, please contact Jenny Liu, Principal Scientist, (firstname.lastname@example.org).
*This Notice was updated on April 2, 2021 to include text regarding test kit evaluations. The Notice was further updated on June 18, 2021 to include mention of using Revision Bulletin to update the footnote with suitable alternative test kit based on the evaluation results.