NOVEL PROCESS FOR THE PREPARATION OF LEVOTHYROXINE SODIUM

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专利权人:

Azico Biophore India Private Limited

发明人:

RAO, Ch. A.P. Rameswara,DASARI, Sreenath

申请号：

EP20140829594

公开号：

EP3024326(B1)

申请日:

2014.01.30

申请国别(地区):

欧洲专利局

年份:

2018

代理人:

摘要：

The present invention provides a novel process for the preparation of highly pure Levothyroxine Sodium, i.e., (S)-2-amino-3-[4-(4-hydroxy-3, 5-diiodophenoxy)-3,5-diiodophenyl] propanoic acid sodium salt via two process intermediates viz 3,5-Diiodo L-Tyrosine copper complex and novel Bis (p-anisyl) iodonium Iodide. The invention also provides levothyroxine pentahydrate free from genotoxic impurities and liothyronine levels below 0.04% wt/wt.

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