Ceftriaxone Sodium NEW

Ceftriaxone sodium has a powerful effect on Escherichia coli, Pneumoniae Bacillus, Indole-positive Proteus, Influenza Bacillus, Serratia, Meningococcus, and Neisseria gonorrhoeae;

Ceftriaxone sodium is used for pneumonia, bronchitis, peritonitis, pleurisy caused by sensitive bacteria, and infections of skin and soft tissues, urinary tract, biliary tract, bones and joints, facial features, wounds, etc.   It is also used for sepsis and meningitis.

Product: CEFTRIAXONE SODIUM STERILE

TEST REFERENCE RESULTS

Description • White to yellowish-orange crystalline powder.   Conforms

Solubility Freely soluble in water, sparingly soluble in methanol, very slightly soluble in alcohol.   Conforms

Identification

) IR: Similar to the reference standard

) HPLC: the retention time of major peak of the sample solution corresponds to that of the standard solution ,as obtained in the assay

) Sodium reaction

Conforms

Conforms

Conforms

Crystallinity Particles should show birefringence (interference colors) and extinction positions Confbnns

pH 6.0~8.0 6.8

Water 8.0%~11.0% 9.2%

Bacterial endotoxins ≤0.20 EU/mg Conforms

Sterility Meets the requirements

(membrane filtration method) Conforms

Assay Not less than 795pg of Ceftriaxone

(C18H18N8O7S3) per mg (on the anhydrous basis) 916ug/mg

Related substances Deacetylcefotaxime lactone(Impurity B RRT:0.20) ≤ 0.5% 7-AminocephaIosporanic acid(RRT:0.34) ≤ 0.5%

Ceftriaxone triazine analog(Impurity C RRT:0.62) ≤ 1.0%

Ceftriaxone benzothiazolyloxime(Impurity D RRT:0.72) ≤ 0.2% Deacyl ceftriaxone(Impurity E RRT: 0.78) ≤ 0.5%

Ceftriaxone 3-ene isomer(RRT:1.3) ≤ 0.3%

Ceftriaxone E-isomer(Impurity A RRT: 1.4) ≤ 0.5%

Any individual unspecified impurity ≤ 0.2%

Total impurities ≤ 2.5% Not detected Not detected 0.08%

Not detected Not detected Not detected 0.01%

0.04%

0.21%

Constituted solution (Completeness and clarity of solution) The material should dissolve completely, leave no visible residue as undissolved matter.   The solution should be as clear as water Conforms

Particulate matters Visual: The solution after  reconsitution is free from particles of foreign matters/black particles that can be observed on visual inspection.   Conforms

Not less than 10um Particles, ≤6000/g 36

Not less man 25um Particles, ≤600/g 3

Tapped density Informative

0.79g/ml 0.79g/ml