BRIEFING

 Metoprolol Succinate Extended-Release Capsules. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

1. The liquid chromatographic procedure in the Assay was validated using the LiChrosorb RP8 brand of column with L7 packing. The typical retention time for metoprolol is about 7 min.

2. The liquid chromatographic procedure in the Dissolution test was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for metoprolol is about 7 min.

3. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Superspher 60 RP-Select B brand of column with L7 packing. The typical retention time for metoprolol is about 7 min.

 (SM2: S. Shane)

 Correspondence Number—C265995