Sulbactam sodium NEW

Cefoperazone Sodium-Sulbactam Sodium: Cefoperazone mainly inhibits the synthesis of bacterial cell walls. Sulbactam itself has weak antibacterial effect and is a competitive and irreversible β-lactamase inhibitor. When combined with cefoperazone, it can increase the ability of cefoperazone to resist degradation by multiple β-lactamases. , Has a significant synergistic effect on cefoperazone.

Product:                                     CEFOPERAZONE SODIUM AND SULBACTAM SODIUM 1:1

TEST REFERENCE RESULTS

Description A white or almost white powder Complies

Solubility Freely soluble in water Complies

Identification

IR :Similar to the reference standard

Sodium:Responds to the test of sodium

Complies

Complies

pH Between 3.5 and 6.5 5.0

Clarity and Color of solution (lg in 4 ml of water) Clear and not more intensely colored than reference solution Y3 Complies

Water Not more than 3.5% 1.9%

Particulate matter Particle≥l0um: Max 3000 44

Particles≥25um: Max 300 7

Bacterial endotoxins Not more than 0.2 EU per mg Complies

Sterility Test Meets the requirements Complies

Assay (as cefbperazone) Not less than 450ug of cefoperazone

 (C25H27N9O8S2)

per mg on anhydrous basis 455ug/mg

Assay (as sulbactam) Not less than 450ug of

sulbactam ( C8H 11NO5S )                             

per mg on anhydrous basis