(R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide;
3-{[(R)-1-Methyl-2-pyrrolidinyl]methyl}-5-[2-(phenylsulfonyl)ethyl]indole, monohydrobromide
[177834-92-3] Monohydrate [273211-28-2]
BRIEFING
Eletriptan Hydrobromide. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed. Based on comments received, the proposal in PF 43(3) has been canceled and is being replaced with a new proposal.
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The LC procedure in the Assay and the test for Organic Impurities, Procedure 1 was validated using the XTerra RP18 brand of column with L1 packing. The typical retention time for eletriptan is about 10 min.
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The LC procedure in the test for Limit of Eletriptan S-Enantiomer was validated using the Chiralpak AD-H brand of column with L51 packing. The typical retention times for eletriptan and eletriptan S-enantiomer are about 25 and 30 min, respectively.
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The GC-MS procedure in the test for Limit of Isopropyl p-Toluenesulfonate was validated using the Rxi-5MS brand of column with G27 phase. It has been indicated to USP that Isopropyl p-toluenesulfonate should be treated as a potential genotoxic impurity associated with some manufacturing processes. The typical retention time for isopropyl p-toluenesulfonate is about 10 min.
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The LC procedure in the test for Organic Impurities, Procedure 2 was validated using the XTerra RP-8 brand of column with L7 packing. The typical retention time for eletriptan is about 12 min.
Description and solubility information: White to light-pale-colored powder. Readily soluble in water.
(SM4: R. Nguyen)
Case ID—SUB-1028
USP REFERENCE STANDARDS FOR PURCHASE
USP Eletriptan Related Compound B RSUSP Eletriptan S-Enantiomer RS
USP Isopropyl p-Toluenesulfonate RS