Ceftriaxone Sodium for injection

TEST ITEMS SPECIFICATION RUSULT Description White or almost white crystalline powder,slightly hygroscopic almost white crystalline powder,slightly hygroscopic Assay(on dry basis)9999.2Identification By IR By HPLC It responds to the tests for sodium Positive Positive Positive PH 6.0-8.0 6.8 Particulate Mater Particles≥25um: not more than 300part/g Particles≥10um: not more than 3000part/g 1 46 Crystallinity Meets requirements Complies Specific optical rotation -153°—-170° -161° Absorption 495—545 523 Heavy Metals ≤ 20.0 ppm Complies Water 8.0%—10.0% 9.4% Sterility It complies with the test for sterility Complies Bacterial endotoxins Less than 0.20EU/mg Complies Assay Not less than 795ug/mg(on the anhydrous basis) 92.7ug/mg Specific Volume(Bulk) For reference 2.6ml/g Specific Volume(Tapped For reference 1.6ml/g Storage condition Be stored in a sterile,air tight container,tamper-proof container.The temperature not exceed 20°C Conclusion The result conforms to USP30