High purity amlodipine benzenesulfonate and a process for...

Details High purity amlodipine benzenesulfonate and a process for... High purity amlodipine benzenesulfonate and a process for...

2006-12-26

2006-12-26

Dentz, Bernard (Department: 1625)

Organic compounds -- part of the class 532-570 series

Organic compounds

Heterocyclic carbon compounds containing a hetero ring...

C514S356000

Reexamination Certificate

active

07153970

ABSTRACT:
3-ethyl 5-methyl (+/−) 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate, containing overall impurities of significantly less than 0.3% is disclosed, as well as process for its preparation, according to which substance of 3-ethyl 5-methyl (+/−) 2-[2-(N-trialkylamino)ethoxymethyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate is converted with benzenesulfonic acid in ethanol solution, at a temperature between 20° C. and reflux temperature, followed by isolation and purification of 3-ethyl 5-methyl (+/−) 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate. Amlodipine benzenesulfonate is useful as an antiishemic and antihypertensive agent.

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Zmitck et al., “Sources of Impurities—Investigation of 4-(2-Chlorophenyl)-3-Ethoxycarbonyl-5-Methoxycarbonyl-6-Methyl-2-[(2-Phthalimidoethoxy)Methyl]-1,4-Dihydropyridine Traces Formation During the Synthesis of Amlodipine Besylate”, Acta Chim. Slov., vol. 47, pp. 63-68 (2000).

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