Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry
ISSN: 0975-413X
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Abstract
Process for producing 6-(2, 3-dichlorophenyl)-1, 2, 4-triazine 3,5-diamine (Lamotrigine) and identification, characterization of a new N-methyl impurity
Author(s): G. Venkanna, D. Nagender, P. Venkateswarlu, K. Chandra Shekhar, G. Madhusudhan and K. MukkantiDisclosed herein is the industrial scalable process for producing the 6-(2,3-dichloro-phenyl)- 1,2,4-triazine-3,5-diamine (Lamotrigine) with 99.9% HPLC purity and high yield in neutral conditions as compared to basic and acidic reaction conditions. The major impurities, A, B, C, D, E, F and G, are listed in European & US pharmacopoeias. We are reporting, an investigated and characterized new impurity (N-methyl impurity) and besides a way to control during the process.
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