BRIEFING

 Loperamide Hydrochloride Tablets. This proposal is based on the version of the monograph official as of May 1, 2020. It is proposed to revise the monograph with the following changes:

1. Delete Identification A using thin-layer chromatography and UV spectroscopy methods. Rename the existing Identification B as Identification A.

2. Add a new Identification B based on the UV spectral agreement, as obtained in the proposed revised Assay.

3. Replace the Assay procedure with a new procedure for consistency with the proposed revisions for the related USP article and Capsules monographs. The liquid chromatographic procedure was validated using the YMC-Triart C18 brand of column with L1 packing. The typical retention time for loperamide is about 6 min.

4. In the Organic Impurities test, the chromatographic procedure has been revised to incorporate specification limits for any unspecified degradation product and the total degradation products. The liquid chromatographic procedure was validated using the ACE Excel Super C18 brand of column with L1 packing. The typical retention time for loperamide is about 27 min.

5. In the Acceptance criteria of the Organic Impurities test, add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

6. Update the Packaging and Storage section to include storage conditions consistent with the product label.

7. Add USP Loperamide Related Compound G RS and update the USP Reference Standards section to be consistent with the current chemical information.

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

 (SM3: J. Kilari)

 Case ID—SUB-799