BRIEFING

 Erythromycin Delayed-Release Tablets. This proposal is based on the version of the monograph official as of April 1, 2023. It is proposed to revise the monograph with the following changes:

1. Add the test for Identification B.

2. Replace the Assay test with a validated HPLC procedure using the ApHera C18 brand of column with L69 packing.

3. Add an Organic Impurities test sharing the same HPLC conditions as in the proposed Assay.

4. Add USP Erythromycin Related Compound N RS to the USP Reference Standards section.

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

 (BIO4: K. Chandra)

 Case ID—SUB-1295