BRIEFING

 Erythromycin Tablets. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise monograph with following:

1. Replace the current Identification test with Identification A and Identification B tests. Both tests use the same HPLC procedure, which was validated using a Purosphere STAR brand of column, with L1 packing.

2. Remove the Loss on Drying test, as it is formulation specific.

3. Add an Organic Impurities test sharing the same HPLC condition as in the proposed Identification A.

4. Add USP Erythromycin System Suitability Mixture 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-1327