Cefotaxime Sodium

CAS number:63527-52-6

Molecular formula:C16H17N5O7S2

molecular weight:455.46500

Chemical structure:

Product Name Cefotaxime Sodium
Shelf life 2 years
Test items Standard Test results

Description

White,off-white to pale yellow crystalline powder,ordorless,or slight special ordor White,crystalline powder slight special ordor
Clarity and color solution

1.The solution is clear            

         2.Absorbance≤0.20

Conforms                            

      0.08

Identification

1.IR spectrum is concordant with RS

Conforms 

2.The retention time of the principal peak in HPLC Chromatogram is identical with RS

Conforms 
3.It responds to the tests for sodium  Conforms 
Specific optical rotation +58.0o-+64.0o +60.0o
pH 4.5-6.5 5.6
Loss on drying ≤3.0% 2.1%

Chromatogram purtiy 

Individual impurity Total impurities

≤1.0%                                

 ≤3.0%

0.41%                                 

1.68% 

Sterility Conforms Conforms
Bacterial endotoxins ≤0.20EU/mg Conforms
Visible particles ≤0.20EU/mg Conforms
Particulate matter

≥10μm:  ≤2000pc/g

       ≥25μm:  ≤200pc/g

330pc/g                              

 30pc/g 

Residue solvent Conforms  Conforms 
Bulk Density ≥0.45g/ml 0.47g/ml
Tapped Density ≥0.65g/ml 0.68g/ml
Assay It contains the equivalent of not less than 916μg/mg and not more than 964μg/mg of cefotaxime,C16H17N5O7S2 calculated on the anhydrate basis. 943μg/mg
CONCLUSION:THE RESULTS CONFORM WITH USP 35 STANDARD