Process for the production of ralfinamide salts substantially free from impurities having genotoxic effects

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United States of America Patent

PATENT NO 9856207
APP PUB NO 20170029365A1
SERIAL NO

15291202

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Abstract

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The invention relates to a new process for the production and/or purification of the salt of the compound (S)-2-[4-(2-fluorobenzyloxy) benzylamino]propanamide, i.e. ralfinamide, or the respective R-enantiomer, with methane sulfonic acid in high yields and very high enantiomeric and chemical purity in the form of the crystalline anhydrous polymorph identified as form A, wherein said salt is substantially free from impurities having genotoxic effect, such as (C1-C5)alkanylmethanesulfonates, and residual solvents known as potential precursors thereof, such as (C1-C5)alkanols or esters thereof with lower alkanoic acids.

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Patent Owner(s)

Patent OwnerAddress
NEWRON PHARMACEUTICALS S P A20091 BRESSO (MI)

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Inventor(s)

Inventor Name Address # of filed Patents Total Citations
Giordano, Claudio Milan, IT 62 181
Waldvogel, Erwin Aesch, CH 6 4

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