BRIEFING

 Dimethyl Fumarate Delayed-Release Capsules. This proposal is based on the version of the monograph official as of December 1, 2023. It is proposed to clarify further dilution in the sample preparation in the Assay and Organic Impurities test to avoid ambiguity. Additionally, it is proposed to revise the monograph with the following changes in the test for Organic Impurities:

1. Revise the Sensitivity solution concentration from 0.48 μg/mL to 0.96 μg/mL to align with the 0.1% reporting threshold.

2. Add Table 2 and a note in the System suitability section to present relative retention times as an aid in peak assignment.

3. Revise Table 3 in the Acceptance criteria to list only the limits for specified degradation products, any unspecified degradation product, and total degradation products.

4. Under the Acceptance criteria, the numerical reporting threshold has been replaced with a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility. For more information about this change, please see the USP Compendial Notice “New Chapter 〈477〉 User-Determined Reporting Thresholds and its implementation in USP−NF monographs”.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 The comment period for this revision ends on September 30, 2024. In the absence of any significant adverse comment, it is proposed to implement this revision via an Interim Revision Announcement with an official date of January 1, 2025.

 (SM4: R. Radhakrishnan)

 Correspondence Number—SUB-588