1-Piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-, monohydrochloride;
4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide hydrochloride [34552-83-5]
BRIEFING
Loperamide Hydrochloride. This proposal is based on the version of the monograph official as of November 1, 2020. It is proposed to revise the monograph with the following changes:
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Add the UNII code of Loperamide Hydrochloride in the Chemical Information section.
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Rename Identification B as Identification C.
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Add Identification B based on the retention time agreement, as obtained in the proposed Assay.
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Replace the titration-based Assay with a liquid chromatographic procedure, which was validated using the YMC-Triart C18 brand of column with L1 packing. The typical retention time for loperamide is about 6 min.
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Replace the liquid chromatographic procedure in the test for Organic Impurities with a more specific procedure for consistency with the proposed revisions with the related Capsules and Tablets monographs. This 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.
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In the Acceptance criteria for the Organic Impurities test, add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.
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Revise the Packaging and Storage section to include the storage temperature.
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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-1491
USP REFERENCE STANDARDS FOR PURCHASE
USP Loperamide Hydrochloride RSUSP Loperamide System Suitability Mixture RS