BRIEFING
Prucalopride Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.
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The liquid chromatographic procedure in the Assay and the test for Organic Impurities was validated using the Kromasil C18 brand of column with L1 packing. The typical retention time for prucalopride is about 21 min.
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The liquid chromatographic procedure in the Dissolution test was validated using the Hypersil GOLD brand of column with L1 packing. The typical retention time for prucalopride is about 2 min.
(SM3: A. Leeks, Jr)
Case ID—SUB-2461