Lercanidipine Dimethyl ester impurity oxalate salt is a synthetic byproduct derived from the esterification of lercanidipine's carboxylic acid moiety with methanol, forming two methyl ester linkages. The compound retains the dihydropyridine core and 2-nitrophenyl substituent of the parent drug but features modified ester functionality, altering its solubility and chromatographic behavior. The oxalate salt form stabilizes the molecule through ionic interactions. This impurity arises during API synthesis due to incomplete acylation or hydrolysis steps. It serves as a critical HPLC reference standard for quantifying process-related impurities in lercanidipine formulations.
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InChI=1S/C21H27N3O6.C2H2O4/c1-12-16(19(25)29-6)18(14-8-7-9-15(10-14)24(27)28)17(13(2)23-12)20(26)30-21(3,4)11-22-5;3-1(4)2(5)6/h7-10,18,22-23H,11H2,1-6H3;(H,3,4)(H,5,6)
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