Hexanamide, 2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl]-, (2S)-, dimethanesulfonate;
(2S)-2,6-Diamino-N-[(1S)-1-methyl-2-phenylethyl]hexanamide dimethanesulfonate;
(S)-2,6-Diamino-N-[(S)-1-phenylpropane-2-yl]hexanamide dimethanesulfonate [608137-33-3]
BRIEFING
Lisdexamfetamine Dimesylate. 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 XBridge BEH C18 brand of column with L1 packing. The typical retention time for lisdexamfetamine is about 7 min.
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The liquid chromatographic procedure in the test for Organic Impurities is based on analyses performed with the XBridge BEH C18 brand of column with L1 packing. The typical retention time for lisdexamfetamine is about 25 min.
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The liquid chromatographic procedure used in the test for Enantiomeric Purity is based on analyses performed with the Chiralpak IF-3 brand of column with L134 packing. The typical retention times for lisdexamfetamine and lisdexamfetamine related compound B are about 8 and 11 min, respectively.
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The gas chromatographic procedure used in the test for Limit of Mesylate Impurities is based on analyses performed with the Rtx-1 brand of column with phase G1. The typical retention times for isopropyl mesylate and propyl mesylate are about 7 and 8 min, respectively.
USP is interested in a validated analytical procedure for the Limit of Mesylate Impurities test which does not require the use of a hazardous reagent.
Description and Solubility information: White to off white powder. Freely soluble in water.
(SM4: G. Daddala)
Case ID—SUB-730