Category
Amlodipine
CAS Number
1216406-90-4
Alternate CAS Number
2414962-06-2(HCl Salt);113994-41-5(Freebase);2138811-33-1(Fumarate Salt);NA(Mesilate Salt);2733700-89-3(besylate salt)
Molecular Formula
C₂₂H₂₅ClN₂O₉
Molecular Weight
496.9 g/mol
Synonym

2-[(2-Aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester oxalate ; 3-Ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate oxalate ; Dehydro Amlodipine Oxalate; 2-(2-Amino-ethoxymethyl)-4-(2-chloro-phenyl)-6-methyl-pyridine-3,5-dicarboxylic Acid 3-ethyl Ester; 3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate;oxalic acid

Keywords
Aromatics
Heterocycles
Impurities
Pharmaceutical Standards
Intermediates
Fine Chemicals
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Amlodipine EP Impurity D (Oxalate Salt) is a recognized related substance of amlodipine identified in the European Pharmacopoeia (EP). It is an impurity that can form during synthesis, salt formation, or storage and exists specifically as the oxalate salt of the impurity. Monitoring this impurity is important to ensure the purity, safety, and efficacy of amlodipine products. Regulatory guidelines like ICH and EP specify acceptable limits for such related substances in quality control.