Type of Posting: Notice of Intent to Revise
Posting Date: 26-Feb-2021; updated 02–Apr–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 not available. The current Sulfite test states “Determine the sulfite content by a suitable enzymatic method…” with a footnote that states “Test kit for sulfite determination may be ordered from Boehringer Mannheim Roche/R-Biopharm, Catalog #10 725 854 035.”
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.” In addition, USP General Notices 6.30. Alternative and Harmonized Methods and Procedures states that “alternative method or procedure must be fully validated and must produce comparable results to the compendial method or procedure within allowable limits established on a case-by-case basis.” Therefore, stakeholders can utilize a suitable enzymatic method with a suitable test kit if the method is validated and produces comparable results to the compendial method.
The Simple Excipients Expert Committee proposes to revise the USP Sucrose monograph to update the footnote by referencing a new suitable test kit. In addition, the footnote will clarify the flexibility to use other suitable test kits, provided they are validated.
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, as the coordinating pharmacopeia of this monograph, is currently leading the effort to to evaluate alternative test kits and will share the evaluation results with PDG. As soon as PDG evaluates the results and makes the decision, USP will publish a revision to the monograph.
As an update to PDG’s evaluation, two alternative test kits from the following suppliers are currently being tested. These are from:
- Megazyme/Neogen: https://www.megazyme.com/total-sulfite-assay-kit-enzymatic
- Nzytech: https://www.nzytech.com/products-services/analytical-products/analytical-test-kits/ak00071/
In addition, PDG is currently 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, Senior Scientific Liaison (email@example.com).
This Notice was updated on April 2, 2021 to include text regarding test kit evaluations.