BRIEFING
Levonorgestrel 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 procedure in the Assay was validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for levonorgestrel is about 4.6 min.
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The liquid chromatographic procedure in the Dissolution was validated using the Inertsil C8 brand of column with L7 packing. The typical retention time for levonorgestrel is about 4.9 min.
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The liquid chromatographic procedure in the Organic Impurities test was validated using the SymmetryShield RP8 brand of column with L7 packing. The typical retention time for levonorgestrel is about 19 min.
(SM5: M. Chang)
Case ID—SUB-1106, SUB-1107