BRIEFING

 Cyclobenzaprine Hydrochloride Tablets. This proposal is based on the version of the monograph official as of October 1, 2023. The following changes are being proposed:

1. Replace the IR spectral agreement test in Identification A with a test based on UV spectral agreement using the proposed Assay to eliminate the use of methylene chloride.

2. Revise the Assay as follows:

   • Revise the Detector in the Chromatographic system to support the proposed Identification A.

   • Update the Chromatographic system to include Run time.

3. Revise the test for Organic Impurities as follows:

   • Add a Sensitivity solution to determine the Signal-to-noise ratio under the Suitability requirements.

   • Add a table and update the Note in the System suitability section to present relative retention times as an aid in peak assignment.

   • Revise Table 2 to list only the limits for specified degradation products, any unspecified degradation product, and total degradation products.

   • In the Acceptance criteria, add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

4. Update the USP Reference Standards section to be consistent with current chemical information.

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

 (SM4: G. Daddala)

 Case ID—SUB-2201