3,5-Pyridinedicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester, (4S)-, (2Z)-2-butenedioate (1:1);
3-Ethyl 5-methyl (S)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate (2Z)-butenedioate [135969-53-8]
BRIEFING
Levamlodipine Maleate. 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 and the test for Organic Impurities was validated using the Symmetry C18 brand of column with L1 packing. The typical retention time for levamlodipine is about 7.5 min.
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The liquid chromatographic procedure used in the test for Limit of Dextroamlodipine was validated using the Ultron ES-OVM brand of column with L57 packing. The typical retention time for levamlodipine is about 12 min.
Description and Solubility information: Off-white to light yellow crystalline powder. Slightly soluble in water and sparingly soluble in ethanol.
(SM2: F. Gu)
Case ID—SUB-282