BRIEFING
Sildenafil for Oral Suspension. 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 procedure in the Assay is based on validation performed with the Symmetry C18 brand of column with L1 packing. The typical retention time for sildenafil is about 10 min.
-
The liquid chromatographic procedure 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 sildenafil is about 10 min.
-
The liquid chromatographic procedure in the test for Organic Impurities is based on validation performed with the Hypersil Gold brand of column with L1 packing. The typical retention time for sildenafil is about 38 min.
(SM5: M. Koleck)
Correspondence Number—C320041