DIRECT PROCESS FOR THE PRODUCTION OF AN AMINO ACID DIHYDROCHLORIDE

Abstract

An amino acid in solution is precipitated with concentrated hydrochloric acid and isolated as the dihydrochloride monohydrate. Said dihydrochloride is redissolved and reprecipitated by adding a solvent.

Description

Claims

1. A process for producing sterile cefepime dihydrochloride monohydrate, according to which a cefepime solution obtained from the synthesis is decolorized with carbon, treated with concentrated HCl to pH 0.4-0.6 at a temperature between 15° and 30° C., then allowed to crystallize for 15-60 minutes and subsequently diluted by adding a water miscible organic solvent over 60-90 minutes at 20°-30° C. until complete precipitation of the crude cefepime dihydrochloride monohydrate, which is then filtered off, redissolved in a solvent chosen from the group consisting of methanol and water at 15°-25° C., filtered sterilely, diluted with the same already used organic solvent over 30-60 minutes in order to induce crystallization, and finally again diluted with the same solvent over 90-150 minutes to complete crystallization of the sterile cefepime dihydrochloride monohydrate, which is filtered off, washed with acetone and dried under vacuum to a K.F. between 3.0% and 4.5%.

2. A process for producing sterile cefepime dihydrochloride monohydrate, wherein a particularly pure aqueous solution of cefepime obtained from the synthesis is decolorized with carbon, filtered sterilely, treated with concentrated HCl to pH 0.4-0.6 at a temperature between 15° and 30° C., then allowed to crystallize for 15-60 minutes and subsequently diluted by adding a water miscible organic solvent over 60-90 minutes at 20°-30° C. until complete precipitation of the sterile cefepime dihydrochloride monohydrate, which is then filtered off, washed with acetone and dried under vacuum to a K.F. between 3.0% and 4.5%.

3. A process as claimed in claim 1, wherein said acidification with concentrated HCl is undertaken until pH 0.5 is achieved.

4. A process as claimed in claim 1, wherein said organic solvent is acetone.

5. A process as claimed in claim 2, wherein said organic solvent is acetone.

6. A process as claimed in claim 1, wherein the crude cefepime dihydrochloride monohydrate is dissolved in methanol, to be then filtered sterilely.

7. A process as claimed in claim 4, wherein the crude cefepime dihydrochloride monohydrate is dissolved in methanol, to be then filtered sterilely.

8. A process as claimed in claim 1, wherein the crude cefepime dihydrochloride monohydrate is dissolved in water, to be then filtered sterilely.

9. A process as claimed in claim 4, wherein the crude cefepime dihydrochloride monohydrate is dissolved in water, to be then filtered sterilely.

10. A process as claimed in claim 1 wherein the sterile cefepime dihydrochloride monohydrate obtained has a density about double that of the product prepared by the known method.