1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-, (R)-, methanesulfonate;
(R)-N-2-Propynyl-1-indanamine methanesulfonate;
(R)-N-(Prop-2-yn-1-yl)indan-1-amine methanesulfonate [161735-79-1]
BRIEFING
Rasagiline Mesylate. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure used in the Assay is based on analyses performed with the Develosil ODS-MG brand of column with L1 packing. The typical retention time for rasagiline is about 5 min.
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The liquid chromatographic procedure in the test for Organic Impurities is based on analyses performed with the Develosil ODS-MG brand of column with L1 packing. The typical retention time for rasagiline is about 12 min.
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The liquid chromatographic procedure used in the Enantiomeric Purity test is based on analyses performed with the Chiralpak AGP brand of column with L41 packing. The typical retention times for rasagiline S-enantiomer and rasagiline are about 7 and 8 min, respectively.
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The proposal includes a test for the Limit of Rasagiline Related Compound B by LC-MS and is based on analyses performed with the Zorbax SB-C18 brand of column with L1 packing. The detection was accomplished with triple quadrupole mass spectrometer with ESI probe and positive ion mode. The typical retention time for rasagiline related compound B is about 6 min.
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The proposal includes a test for the Limit of Mesylate Impurities by GC-MS and is based on analyses performed with the DB-624 brand of column with phase G43. The typical retention times for methyl mesylate, ethyl mesylate, and isopropyl mesylate are about 10, 11, and 12 min, respectively.
Description and solubility information: White to off-white powder. Freely soluble in water and in ethanol; sparingly soluble in isopropanol.
(SM4: G. Daddala)
Case ID—SUB-844