BRIEFING
Dutasteride Capsules. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed. On the basis of comments received, the proposal that appeared in PF 46(5) [Sep.–Nov. 2020] has been canceled and is being replaced with a new proposal.
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The liquid chromatographic procedure in the Assay is based on validation performed with the Zorbax SB-C18 brand of column with L1 packing. The typical retention time for dutasteride is about 6 min.
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The liquid chromatographic procedure in Dissolution Test 1 is based on analyses performed with the Zorbax SB-C18 brand of column with L1 packing. The typical retention time for dutasteride is about 6 min.
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The liquid chromatographic procedure in Dissolution Test 2 is based on analyses performed with the Vydac 218TP brand of column with L1 packing. The typical retention time for dutasteride 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 Zorbax SB-C18 brand of column with L1 packing. The typical retention time for dutasteride is about 41 min.
(SM5: M. Koleck)
Correspondence Numbers—C211875; C314272