BRIEFING

 Aminocaproic Acid. This proposal is based on the version of the monograph official as of May 1, 2020. The following changes are proposed:

1. Update the molecular weight of Aminocaproic Acid to be consistent with the USP Dictionary.

2. Revise Identification A to provide the flexibility of using either 197A or 197K.

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

4. Replace the use of methionine reagent with USP l-Methionine RS as the internal standard in the Assay.

5. Add column particle size in the Assay.

6. Revise the percent relative standard deviation requirement in the Assay to align with the maximum permitted percent RSD in Chromatography 〈621〉.

7. Add a liquid chromatographic procedure-based Organic Impurities test which is based on validation performed using the Acclaim 120 C18 brand of column with L1 packing. The typical retention time for aminocaproic acid is about 9 min.

8. Add USP l-Methionine RS, USP Aminocaproic Acid Related Compound A RS, USP Aminocaproic Acid Related Compound B RS, and USP Caprolactam RS to the USP Reference Standards section to support the Assay and 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-430