BRIEFING
Nebivolol Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedures in the Assay and the Dissolution test are validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for nebivolol is about 5.5 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Sunfire C18 brand of column with L1 packing. The typical retention time for nebivolol is about 9 min.
(SM2: S. Ramakrishna)
Correspondence Number—C109140