BRIEFING

 Carbamazepine 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 Zorbax Eclipse XDB-C18 brand of column with L1 packing. The typical retention time for carbamazepine is about 18 min.

2. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Zorbax Eclipse XDB-C8 brand of column with L7 packing. The typical retention time for carbamazepine is about 11 min.

 (SM4: P. Jagu)

 Correspondence Number—C209844