BRIEFING

  Mometasone Furoate Topical Solution. This proposal is based on the version of the monograph official as of December 1, 2022. It is proposed to revise the monograph with the following changes:

1. Replace the TLC-based Identification B with the UV spectral agreement of the mometasone furoate peak of the Sample solution and the Standard solution, as obtained in the Assay. The detector in the Assay is updated accordingly.

2. Clarify the Note about protecting solutions from light in both the procedures for the Assay and the Organic Impurities test.

3. Update the Sample solution preparation in the Assay and Organic Impurities test to provide flexibility.

4. Tighten the requirement for the Relative standard deviation from NMT 2.0% to NMT 1.0% in the Assay based on supporting data, to be consistent with the expectations of a modern chromatographic system.

5. Update the calculation in the Analysis of the Assay to be consistent with the Definition.

6. Add the Standard solution and replace the System suitability solution with the Standard solution for the Relative standard deviation requirement, which is proposed to be changed from NMT 10.0% to NMT 5.0%, in the Organic Impurities test based on supporting data, to be consistent with the expectations of a modern chromatographic system.

7. Add a table to the System suitability section in the Organic Impurities test to present relative retention times as an aid in peak assignment. Revise the table in the Acceptance criteria section to list only the limits for specified impurities, any unspecified impurity, and total impurities.

8. Add impurities with relative retention times of 1.04 and 1.13 to Table 2, update the chemical names and trivial names in Table 2 and Table 3 to be consistent with USP style, and revise the terminologies for unspecified and total impurities to be consistent with International Council for Harmonisation terminologies in the Organic Impurities test.

9. Revise the Note in the Analysis section of the Organic Impurities test.

10. Delete the reference to Microbial Enumeration Tests 〈61〉 as there is no related acceptance criteria.

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

 (SM2: S. Parepalli)

 Correspondence Number—C323516