BRIEFING
Tiagabine Hydrochloride Tablets. 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) [Sept.–Nov. 2020] has been canceled and is being replaced with this new proposal.
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The liquid chromatographic procedure in the Assay is based on validation performed using the Acquity UPLC BEH C18 brand of column with L1 packing. The typical retention time for tiagabine is about 1.4 min.
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The liquid chromatographic procedure in the test for Organic Impurities is based on validation performed using the Symmetry C18 brand of column with L1 packing. The typical retention time for tiagabine is about 43 min.
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The liquid chromatographic procedure in the test for Dissolution is based on validation performed using the ACE C18 brand of column with L1 packing. The typical retention time for tiagabine is about 2.5 min.
(SM4: P. Jagu)
Correspondence Number—C213353