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Reporting Thresholds in Monographs- Proposed General Chapter <477> User-Determined Reporting Thresholds

Type of Notice: General Announcement
Posting Date: 26-Aug-2022

The General Chapters–Chemical Analysis Expert Committee and USP staff have completed work on a proposed general chapter to aid users in determining an appropriate numeric value for the reporting threshold in chromatographic test procedures.  The new general chapter would be applicable when a user-determined reporting threshold is specified in the individual monograph. The proposed development of this general chapter was previously announced in the General Chapter Prospectus: <477> User-Determined Reporting Thresholds.

The approach described in the proposed general chapter was refined based on feedback from diverse stakeholder groups and input from USP Expert Volunteers. A previous Compendial Notice on this topic may be found at USP Virtual Roundtable on Reporting Thresholds in Monographs (held on June 29, 2021).

The proposed General Chapter <477> User-Determined Reporting Thresholds will be published in the Pharmacopeial Forum 48(5) and remains open for stakeholder comment until November 30, 2022. Your engagement is encouraged.

Should you have any questions, please contact Nicholas Garito, Principal Scientist (301-816-8321,