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PROCESS FOR THE PURIFICATION OF BIAPENEM

IP.com Disclosure Number: IPCOM000238978D
Publication Date: 2014-Sep-29
Document File: 2 page(s) / 33K

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Abstract

Disclosed herein is a process for the purification of biapenem. The purification of biapenem comprises adjusting the pH of a biapenem solution, followed by treatment of the biapenem solution with an antisolvent, and isolation of the biapenem.

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PROCESS FOR THE PURIFICATION OF BIAPENEM

Abstract

Disclosed herein is a process for the purification of biapenem.  The purification of biapenem comprises adjusting the pH of a biapenem solution, followed by treatment of the biapenem solution with an antisolvent, and isolation of the biapenem.

            Biapenem is chemically known as 6-[[2(4R,5S,6S)-carboxy-6-[(1R)-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-en-3-yl]thio]6,7-dihydro-5H-pyrazolo[1,2-a][1,2,4] triazol-4-ium inner salt and is represented by Formula I.  It is indicated for the treatment of bacterial infection and sepsis.

Formula I

Reported herein is a process for the purification of biapenem, wherein the process comprises adjusting the pH of a biapenem solution, followed by treatment of the biapenem solution with an antisolvent, and isolation of the biapenem.

Also reported herein is a process for the purification of biapenem, wherein the process comprises the steps of:

(a)     treating an aqueous mixture of biapenem with an acid;

(b)     adjusting the pH of the solution obtained in step (a) to 5.1 to 5.5;

(c)     optionally treating the solution obtained in step (b) with activated charcoal;

(d)    filtering the activated charcoal from the mixture obtained in step (c); and

(e)     adding acetone to the solution obtained in step (b) or step (d).

The biapenem to be purified (starting material) can be obtained using known methods, for example, by the processes described i...