Ofloxacin CAS 82419-36-1 and Levofloxacin Hemihydrate CAS 138199-71-0
Product |
Ofloxacin |
Levofloxacin Hemihydrate |
Synonyms: |
Ofloxacinum, Ofloxacine |
Levofloxacine |
CAS |
82419-36-1 |
138199-71-0 |
Appearance: |
A pale yellow or bright yellow, crystalline powder |
Yellowish crystalline powder |
Assay |
98.5% ~ 101.5% |
98.5% Min |
Formula: |
C18H20FN3O4 |
C18H20FN3O4·1/2H2O |
Structure: |
||
Packing info |
25Kg/Cardboard Drum |
25Kg/Cardboard Drum |
Certificate of Analysis: Levofloxacin Hemihydrate
Name of product |
Ofloxacin |
|
Analytical items |
Specifications |
Analytical results |
Characteristics |
White or Light yellow green crystalline powder |
Complies |
Identification |
A: IR test B: UV test |
Complies Complies |
Specific rotation D20 |
-1°~+1° |
+0.26° |
Residual Solvents A: Methanol B: Ethanol |
≤0.005% ≤0.05% |
<0.005% <0.05% |
Purity test (HPIC) A: Individual impurity B: 9-desfluoroofloxacin C: Total impurity |
≤0.3% ≤0.2% ≤0.5% |
0.11% 0.09% 0.23% |
Heavy metals |
≤0.001% |
<0.001% |
Arsenic |
≤1ug/g |
Complies |
Assay (on the dried basis) |
≥98.5% |
99.2% |
Certificate of Analysis: Levofloxacin Hemihydrate
ITEMS |
STANDARD |
RESULTS |
Appearance |
Yellowish crystalline powder |
Yellowish crystalline powder |
Specific optical rotation |
-92°— -99° |
-97.2° |
Identification IR |
IR spectrum of sample conforms to that of reference standard. |
complies |
Identification HPLC |
The retention time of the major peak in the chromatogram of the sample correspons to that of reference standard. |
complies |
PH of solution |
6.8~7.6 |
7.0 |
Clarity of solution |
Clear or its opalescence is not more pronounced than that of reference suspension 1.0 |
Clear |
UV absorbance |
≤0.05 |
0.002 |
Water |
2.1%~2.7% |
2.7% |
Impurity A |
≤0.2% |
<0.2% |
Impurity B |
≤0.2% |
0.07% |
Impurity C |
≤0.2% |
Not found |
Any other impurity |
≤0.1% |
0.05% |
Sum of impurities |
≤0.5% |
0.14% |
R-ofloxacin |
≤0.5% |
0.22% |
Ethanol |
≤0.1% |
0.062% |
DMSO |
≤0.1% |
Not found |
Chloroform |
≤0.006% |
0.0057% |
Residue on ignition |
≤0.1% |
0.04% |
Heavy metals |
≤10 ppm |
3ppm |
Assay (on anhydrous basis) |
98.0%~102.0% C18H20FN3O4 |
99.5% |