| Function: | Antibiotic and Antimicrobial Agents |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | Analysis reagent |
| State: | Solid |
| Volatile: | Not Volatile |
| appearance: | White Crystalline Powder |
| Samples: |
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| Customization: |
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Audited Supplier | Items of Test | Standard | Result of Test |
| Appearance | White or light yellow crystalline powder | conform |
| Identification | ||
| (a) IR | IR spectrum of sample corresponds to that of reference standard. | Conform |
| The intensity and RF value of the principal band obtained from the test solution corresponds to that obtained from the standard solution. | ||
| (b) TLC | A solution of IIresponds to the tests of chloride | Conform |
| (c) the reaction of chloride | Conform | |
| Related substances HPLC | Chromatographic purity ≤ 0.2% | 0.15% |
| Ciprofloxacin ethylenediamine analog ≤ 0.2% | <0.11% | |
| Unspecified impurity ≤ 0.50% | 0.40% | |
| Total impurities ≤ 0.5% | ||
| Ph | 3.0-4.5 | 3.7 |
| Heavy metals | ≤20ppm | <20ppm |
| Fluoroquinolonic acid | ≤0.2% | Conform |
| Sulphated ash | ≤0.04% | <0.04% |
| Water | 4.7%-6.7% | 5.90% |
| Residue of ignition | ≤0.1% | 0.05% |
| Residual solvent | ethanol ≤ 5000ppm | 560ppm |
| Isoamyl alcohol≤ 4000ppm | Not found | |
| Assay (HPLC) | 98.0%-102% | 99.80% |
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