BRIEFING
Progesterone Capsules. 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 used in the Assay is based on analyses performed with the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for progesterone is about 10 min.
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The liquid chromatographic procedure in Dissolution Test 1 is based on analyses performed with the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for progesterone is about 4 min.
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The liquid chromatographic procedure in Dissolution Test 2 is based on analyses performed with the Zorbax SB C8 brand of column with L7 packing. The typical retention time for progesterone is about 4 min.
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The liquid chromatographic procedure in the test for Organic Impurities is based on analyses performed with the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for progesterone is about 16 min.
(SM5: G. Daddala)
Case ID—SUB-1187, SUB-1401