BRIEFING

 Diltiazem Hydrochloride Extended-Release Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures in the Assay and Organic Impurities test are based on validations performed with the Synergi Hydro-RP brand of column with L96 packing. The typical retention time for diltiazem is about 10 min.

 (SM2: I. Salahudeen)

 Correspondence Number—C309450