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2138811-33-1Amlodipine EP Impurity D (Fumarate salt)

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Catalogue No.:	VL19024
CAS No.:	2138811-33-1
Mol. Formula:	C20H23ClN2O5. C4H4O4 (Fumarate Salt)
Mol. Weight:	406.0 g/mol (Free Base); 522.93 g/mol (Fumarate Salt)

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Additional information on CAS 2138811-33-1

Parent drug

Amlodipine

IUPAC Name

3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate Fumarate

Smiles

COC(=O)C1=C(C(=C(N=C1COCCN)C)C(=O)OC)C2=CC=CC=C2Cl.C(=CC(=O)O)C(=O)O

Pharmacopeial Synonyms

Amlodipine Related Compound A

Synonyms

2-[(2-Aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-3,5- pyridine dicarboxylic Acid 3-Ethyl 5-Methyl Ester Fumarate Salt

InChI

InChI=1S/C20H23ClN2O5.C4H4O4/c1-4-28-20(25)18-15(11-27-10-9-22)23-12(2)16(19(24)26-3)17(18)13-7-5-6-8-14(13)21;5-3(6)1-2-4(7)8/h5-8H,4,9-11,22H2,1-3H3;1-2H,(H,5,6)(H,7,8)/b;2-1+

Pharmacopoeial Synonyms

Amlodipine Related Compound A (Fumarate Salt)

Other Synonyms

2-[(2-Aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-3,5- pyridine dicarboxylic Acid 3-Ethyl 5-Methyl Ester Fumarate Salt

Description

Amlodipine EP impurity D, also designated Amlodipine Related Compound A, is the fumarate salt of a substituted dihydropyridine-related pyridine dicarboxylate impurity, CAS 2138811-33-1. It corresponds to 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester, with molecular formula C20H23ClN2O5·C4H4O4 and molecular weight 522.93 g/mol as the fumarate salt, 406.0 g/mol as free base. This structurally defined process-related impurity may arise during esterification, incomplete cyclization, or side-reaction profiling in amlodipine synthesis. Its determination commonly requires LC-MS/MS, LC-HRMS, and stability-indicating HPLC methods, with attention to trace-level coelution and pharmacopoeial impurity specification.