(+)-(R)-2,3,4,9-Tetrahydro-3-(methylamino)-1H-carbazole-6-carboxamide butanedioate (1:1), monohydrate;
(R)-3-(Methylamino)-2,3,4,9-tetrahydro-1H-carbazole-6-carboxamide succinate (1:1), monohydrate [158930-17-7]
BRIEFING
Frovatriptan Succinate. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The proposal for this drug substance which appeared in PF 41(5) was canceled and is replaced with a new proposal.
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The liquid chromatographic procedures in the Assay and Organic Impurities test are based on validation performed with the Inertsil C8-3 brand of column with L7 packing. The typical retention time for frovatriptan is about 6 min in the Assay and about 12 min in the test for Organic Impurities.
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The liquid chromatographic procedure in the Limit of D-Camphor Sulfonic Acid test is based on validation performed with the Zorbax SB C8 brand of column with L7 packing. The typical retention time for D-camphor sulfonic acid is about 7 min.
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The liquid chromatographic procedure in the Limit of Frovatriptan Enantiomer test is based on validation performed with the Chiralpak AS-H brand of column with L90 packing. The typical retention time for frovatriptan is about 8 min.
Description and solubility information: White to off-white powder. Soluble in water; very slightly soluble in methanol.
(SM4: H. Ramanathan)
Case ID—SUB-1033, SUB-2639
USP REFERENCE STANDARDS FOR PURCHASE
USP D-camphor sulfonic acid RSUSP Frovatriptan Racemate RS
USP Frovatriptan Related Compound A RS
USP Frovatriptan Succinate RS