BRIEFING
Tretinoin 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 in the Assay is based on analyses performed with the Hypersil Gold aQ brand of column with L1 packing. The typical retention time for tretinoin is about 12 min.
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The liquid chromatographic procedure in the Organic Impurities test is based on analyses performed with the Acquity UPLC HSS C18 SB brand of column with L1 packing. The typical retention time for tretinoin is about 17 min.
(SM3: J. Kilari)
Case ID—SUB-558