1H-Benzimidazole, 2-[(R)-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-;
(+)-2-[(R)-{[3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl}sulfinyl]-1H-benzimidazole;
2-[(R)-[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole [138530-94-6]
BRIEFING
Dexlansoprazole. 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 procedures for the Assay, Organic Impurities, and Limit of Dibenzimidazole Lansoprazole tests were validated with the XBridge BEH Shield RP18 brand of column with L1 packing. The typical retention time for dexlansoprazole is about 15 min.
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The liquid chromatographic procedure for the Enantiomeric Purity test was validated with the Chiralcel OD-H brand of column with L40 packing. The typical retention time for dexlansoprazole is about 7 min.
Description and solubility information: White to off-white powder. Freely soluble in dimethylformamide; soluble in methanol; slightly soluble in ethyl acetate and in acetonitrile; practically insoluble in water and in n-hexane.
(SM3: V. Durga Prasad)
Case ID—SUB-1879
USP REFERENCE STANDARDS FOR PURCHASE
USP Dexlansoprazole RSUSP Lansoprazole RS
USP Lansoprazole Related Compound A RS