TEST REPORT | ||
ITEM | SPE | RESULT |
Appearance | Slightly yellow or pale orange yellow crystalline powder | Slightly yellow crystalline powder |
ldentification | Meet the requirements | Meet the requirements |
Melting range | 221~-226C | 223.5-224.5C |
Heavy metals | ≤20ppm | <20ppm |
Loss on drying | ≤0.5% | 0.07 % |
Residue on ignition | ≤0.2% | 0.03% |
Related substances | Ciprofoxacin ≤0.5% | 0.14% |
Any otherr single impurity ≤0.3% | 0.14% | |
Total impuries ≤ 0.7% | 0.14% | |
Fluoroquinolonie acid (TLC) | ≤0.2% | <0.2% |
Assay | ≥99.0% (Drled substasce) | 100.1% |