Process for the preparation of crystalline imipenem

• US 20050004359A1
• Filed: 11/18/2002
• Published: 01/06/2005
• Est. Priority Date: 11/16/2001
• Status: Active Grant

• Current Assignee: Ranbaxy Laboratories Limited (Sun Pharmaceutical Industries Limited)
• Original Assignee: Ranbaxy Laboratories Limited (Sun Pharmaceutical Industries Limited)
• Inventors: Kumar, Yatendra, Tewari, Neera, Rai, Bishwa Prakash
• Granted Patent: US 7,332,600 B2
• Time in Patent Office: Days
• US Class Current: 540/350
• CPC Class Codes: C07D 477/20 Sulfur atoms

Abstract

The present invention relates to a cost effective and industrially advantageous process for the preparation of imipenem of high purity.

Claims

1. A process for the preparation of crystalline imipenem monohydrate of Formula I

2. The process according to claim 1 wherein the crude imipenem is dissolved in water which is preheated to a temperature of about 35°

C. to about 60°

C.

3. The process according to claim 2 further comprises adding a base to water to maintain the pH of the hot solution at about 7.5 to 8.5.

4. The process according to claim 3 wherein the base is sodium bicarbonate.

5. The process according to claim 1 wherein the amount of water is about 30 to 60 ml per 1 g of crude imipenem.

6. The process according to claim 1 wherein the carbon treatment is carried out at an ambient temperature.

7. The process according to claim 1 wherein the carbon treatment is carried out at a pH of about 5 to 7.

8. The process according to claim 1 wherein the carbon treatment is carried out in the presence of sodium bisulfite.

9. The process according to claim 1 wherein the organic solvent comprises a lower alcohol, a ketone, and mixture(s) thereof.

10. The process according to claim 9 wherein the lower alcohol is selected from the group consisting of methanol, ethanol, propanol, isopropanol, and mixture(s) thereof.

11. The process according to claim 9 wherein the ketone is acetone, methyl ethyl ketone and a mixture thereof.

12. The process according to claim 1 wherein the crystallization is carried out at a temperature below 25°

C.

13. The process according to claim 12 wherein the temperature is from about 0°

C. to about 15°

C.

14. A compound having the structure of Formula I

15. The compound according to claim 14 which is more than 98% pure.