Levamlodipine Tablets

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BRIEFING

Levamlodipine 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 used in the Assay and Organic Impurities test are based on validation performed with the Symmetry C18 brand of column with L1 packing. The typical retention time for levamlodipine is about 7.5 min.
The liquid chromatographic procedure used in the test for Dissolution is based on validation performed with the Symmetry C18 brand of column with L1 packing. The typical retention time for levamlodipine is about 3.5 min.

(SM2: F. Gu)

Case ID—SUB-382

USP REFERENCE STANDARDS FOR PURCHASE

USP Amlodipine Besylate RS
USP Levamlodipine Maleate RS

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