Varieties: | Other |
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Component: | Chemical Synthetic Drugs |
Type: | Other |
Pharmacodynamic Influential Factors: | Other |
Storage Method: | Prevent Exceeding Quality Guarantee Period |
Veterinary Reg. No.: | Other |
Customization: |
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Analytical Items | Specifications | Analytical Results |
characteristic | white or light yellow crystalline power | Complies |
Identification (a) IR (b) TLC |
IR spectrum of sample conforms that of reference standard,The intensity and RF value of the principal band obtained from the test solution corresponds that obtained from the Standard solution | Complies |
(c) Reation of Chloride | A solution of II responds to tests for Chloide | Complies |
PH | 3.0~4.5 | 3.4 |
Sulfate | ≤0.04% | <0.04% |
Water | 4.7~6.7% | 0.062 |
Residue onignition | ≤0.1% | 0.0004 |
Heavy metals | ≤20ppm | <20ppm |
Fluoroquinolonic acid | ≤0.2% | Complies |
Chromatographic purity | ||
Ciprofloxacin ethylenedianmine analog | ≤0.2% | 0.0017 |
Any other impurity | ≤0.2% | 0.001 |
Total imprities | ≤0.5% | 0.0041 |
Residual solvents | 530ppm | |
Ethanol | ≤4000ppm | Not found |
Isoamyl alcohol | ≤4000pm | |
Assay(on anhydrous basis) | 98.0%~102.0% of C17H18FN3O3HCL | 0.998 |
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