Items | Specification | Results |
C haracter | It is white or similar white crystalline powder or crystalline. | white powder |
S pecific rotation | +179°--- +200° | 186.4° |
I dentify |
|
The retention time of the main peak of the tested product was consistent with that of the control product.
Consistent with that of the control spectra . Show the flame reaction of sodium salt. |
P H | 6.0~8.0 | 6.9 |
Solution clarification | Should be clarified. If turbidity appears, it does not exceed no. 1 turbidity of the standard liquid | clarification |
Solution Color | Not exceeding yellow no. 3 standard colorimetric liquid | < Y 0.5 |
I mpurity |
A single impurity does not exceed 1.5%
Total impurities should not exceed 3.0% |
0.4%
0.7% |
R esidual solvent |
Ethanol, acetone isopropanol, ethyl acetate shall not exceed 0.5%
Methylene chloride must not exceed 0.3% |
Conform |
Aloxicillin polymer | Not more than 0.3% (as A loxicillin ) | Conform |
B acterial endotoxin | Endotoxin levels per 1mg of aroxicillin should be less than 0.07EU | Conform |
S terility | Comply with the standard | Conform |
V isible particles |
No visible foreign matter should be detected
No more than 3 fine foreign bodies should be detected |
Conform |
I rresoluble particulate | Particles containing more than m per 1.0g shall not exceed 6000 | Conform |
C ontent determination | The amount containing aloxicillin (C20 H23 N5 O6 S) shall not be less than 90.0% (As anhydrous substances ) | 95.3% |
Conclusion : The above results are in compliance with Ch.P.2015 |