BRIEFING

 Amiodarone Hydrochloride in Dextrose Injection. 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 in the test for Organic Impurities were validated using the Symmetry C8 brand of column with L7 packing. The typical retention time for amiodarone is about 10 min.

 (SM2: S. Parepalli)

 Case ID—SUB-464