BRIEFING

 Aminocaproic Acid 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. Replace the IR-based Identification A with UV spectrum agreement of the major peak of the Sample solution and Standard solution, as obtained in the proposed Assay, to align with current USP practices. The detector in the Assay is revised accordingly to include the information to run Identification A.

2. Add Identification B based on the retention time agreement of the major peak of the Sample solution and Standard solution, as obtained in the proposed Assay.

3. Replace the titrimetric Assay method with a validated LC procedure. The procedure was validated using the ACE-5-C18 brand of column with L1 packing. The typical retention time for aminocaproic acid is about 6 min.

4. Update Dissolution Test 1 as follows:

   • Include the preparation for the Derivatizing reagent solution, Derivatized standard solution, and Derivatized sample solution.

   • Add a dilution step for the Sample solution for flexibility, if necessary.

   • Add a reference to Ultraviolet-Visible Spectroscopy 〈857〉 in the Instrumental conditions.

   • Add a formula to calculate the percentage of the labeled amount of aminocaproic acid dissolved.

5. Update Dissolution Test 2 as follows:

   • Clarify the Standard solution and Sample solution to align with current USP style.

   • Remove the Autosampler temperature to align with USP General Notices.

6. Add a liquid chromatographic Organic Impurities test which was validated using the Acclaim 120 C18 brand of column with L1 packing. The typical retention time for aminocaproic acid is about 9 min.

7. Add the storage temperature requirement to the Packaging and Storage section based on approved storage conditions.

8. Update the Labeling section to be consistent with current USP style.

9. Add USP Caprolactam RS to the USP Reference Standards section to support the test for Organic Impurities.

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

 (SM2: H. Ramanathan)

 Case ID—SUB-782

 Current Doc ID: GUID-533B5F61-CDDD-42CB-9AA3-411AB1C0757E_4_en-US