BRIEFING

 Clorazepate Dipotassium Tablets. 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. Add Identification B by UV spectral agreement using the proposed Assay.

2. Replace the Assay, and Organic Impurities, Method 1 and Organic Impurities, Method 2 with consolidated liquid chromatographic procedures. These procedures were validated using the Cortecs C18 brand of column with L1 packing. The typical retention time of clorazepate dipotassium is about 4 min.

3. Revise the Dissolution test with the following:

   • Include the equation for calculation of tolerances (Q).

   • Add a reference to Ultraviolet-Visible Spectroscopy 〈857〉 for consistency with current practice

4. Revise the Uniformity of Dosage Units test to delete the procedure for content uniformity per current USP practices.

5. Replace the numerical reporting threshold in the Acceptance criteria section of the Organic Impurities test with a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

6. Add the storage requirement in the Packaging and Storage section for consistency with FDA-approved package inserts.

7. Remove USP 2-Amino-5-chlorobenzophenone RS and add USP Benzophenone RS in the USP Reference Standards section to align with the Reference Standards used in the Organic Impurities procedure. Update the chemical information for USP Nordazepam RS.

 Manufacturers are encouraged to submit their FDA-approved specifications to USP if they are different from those proposed.

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

 (SM4: S. Dragan)

 Case ID—SUB-1331