Di-acid Amlodipine is a dihydroxy-oxidized derivative of amlodipine, featuring two additional carboxylic acid groups introduced via oxidative cleavage of the pyridine ring side chain. This impurity retains the 1,4-dihydropyridine core and chlorophenyl substitution characteristic of the parent drug but exhibits altered polarity and reduced lipophilicity due to the dicarboxylic acid moieties. It arises as a specific degradation byproduct under acidic hydrolysis conditions, serving as a critical reference standard for HPLC-based impurity profiling in amlodipine bulk drug substance analysis.
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InChI=1S/C17H19ClN2O5/c1-9-13(16(21)22)14(10-4-2-3-5-11(10)18)15(17(23)24)12(20-9)8-25-7-6-19/h2-5,14,20H,6-8,19H2,1H3,(H,21,22)(H,23,24)
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