Powder: | No |
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Customized: | Non-Customized |
Certification: | GMP, ISO 9001, USP, BP |
Suitable for: | Elderly, Children, Adult |
State: | Solid |
Purity: | >99% |
Samples: |
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Customization: |
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Items | Specification | Results |
Character | It is white or similar white crystalline powder or crystalline. | white powder |
Specific rotation | +179°--- +200° | 186.4° |
Identify |
|
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. |
PH | 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 |
Impurity | A single impurity does not exceed 1.5% Total impurities should not exceed 3.0% |
0.4% 0.7% |
Residual 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 Aloxicillin) | Conform |
Bacterial endotoxin | Endotoxin levels per 1mg of aroxicillin should be less than 0.07EU | Conform |
Sterility | Comply with the standard | Conform |
Visible particles | No visible foreign matter should be detected No more than 3 fine foreign bodies should be detected |
Conform |
Irresoluble particulate | Particles containing more than m per 1.0g shall not exceed 6000 | Conform |
Content determination | The amount containing aloxicillin(C20H23N5O6S) shall not be less than90.0% (As anhydrous substances) | 95.3% |
Conclusion:The above results are in compliance with Ch.P.2015 |
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