Quality Spec.: (Clinic No. of Approval: 2004L04244)

(balofloxacin)

 

C₂₀H₂₄FN₃O₄.2H₂O   425.46 

 

 

[Appearance] white or light yellow crystalline powder            

 

[Examination]       

Clarity and Color           Less than 1# turbidity standard               

of Solution       less than 4#standard color solution              

Moisture               8.0%-8.9% 

Residue on ignition          No more than 0.2%                   

Fluorine                No less than 4.40%                  

Heavy metal         No more than 20ppm                    

Related Substances          Less than 1.0%                   

 

[Assay]   Balofloxacin(C₂₀H₂₄FN₃O₄): no lower than 99.0%.