BRIEFING

 Loperamide Hydrochloride Capsules. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph with the following changes:

1. Replace the thin-layer chromatography test in Identification A with a UV spectrum agreement, as obtained in the proposed Assay.

2. Replace the Assay with a specific liquid chromatographic procedure, which was validated using the YMC-Triart C18 brand of column with L1 packing, to be consistent with the USP article and Tablets monographs. The typical retention time for loperamide is about 6 min.

3. Add a new Organic Impurities test based on a liquid chromatographic procedure, which was validated using the ACE Excel SuperC18 brand of column with L1 packing. The typical retention time for loperamide is about 28 min.

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

5. Add USP Loperamide Related Compound F RS and USP Loperamide Related Compound G RS to the USP Reference Standards section based on the proposed Organic Impurities test.

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

 (SM3: J. Kilari)

 Case ID—SUB-1358; SUB-1387