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Process for the production of ralfinamide salts substantially free from impurities having genotoxic effects
专利权人:
Claudio Giordano;Erwin Waldvogel
发明人:
Claudio Giordano,Erwin Waldvogel
申请号:
US13643716
公开号:
US09505708B2
申请日:
2011.04.06
申请国别(地区):
US
年份:
2016
代理人:
摘要:
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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