Saccharin

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 28-Feb-2014 (updated 27-Feb-2017*)

Official Date: 01–Dec–2014

Expert Committee: Monographs—Excipients

*Coordinating Pharmacopeia: USP

A revision to the harmonized standard for Saccharin has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 sign-off Rev.1 cover sheet. This revision to the Saccharin 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 revisions to existing tests:

  • Clarity of Solution
    • Deleted “and to water” from the Note, so it reads as “Note - The Sample solution is to be compared to Reference suspension A in diffused daylight 5 min after preparation of Reference suspension A.”
  • Color of Solution
    • Under Standard solution, changed the Note from “Prepare the Standard solution immediately before use.” to “Prepare the Standard stock solution and Standard solution immediately before use.”

In addition, the monograph has been edited to be consistent with the current USP style guide.

The Saccharin monograph will be incorporated into and become official with the Second Supplement to USP 37–NF 32.

*Should you have any questions about the Benzyl Alcohol monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or rll@usp.org).

*The previous PDG sign-off  Cover Pages and Stage 6 postings are included as below: