(WATERSOLUBLE FOR ANIMAL)
| Item | Specification | Results | |
| Appearance | Yellow crystalline powder | Conforms | |
| Solubility | Freely soluble in water and in methanol sparingly soluble. In ethanol(96%), it dissolves in solutions of alkali hydroxides and carbonates | Conforms | |
| Identification |
A: tr
of HPLC test
B: Sulphuric acid yellow Color reaction C: Chloride's reaction
|
Conforms | |
| Ph | 2.0-3.0 | 2.4 | |
| Specific optical rotation(anhydrous and ethanol-free substance) | -120°~-105° | -111° | |
| Specific Absorbance(anhydrous and ethanol-free substance) | At 349nm(E: 1%): 300-335 | 324 | |
| Related substances | 6-epidoxycycline | ≤2.0% | 1.45 |
| Metacycline | ≤2.0% | 0.32 | |
| 4- epidoxycycline | ≤0.5% | 0.1 | |
| 4- epi-6- epidoxycycline | ≤0.5% | Not found | |
| Oxyteracycline | ≤0.5% | Not found | |
| Impurity F | ≤0.5% | 0.18 | |
| Any unspecified impurity | ≤0.5% | 0.01 | |
| Heavy metals | ≤50ppm | ＜50ppm | |
| Ethanol | 4.3-6.0% | 5.0 | |
| Sulphated ash | ≤0.4% | 0.08 | |
| Water | 1.4%-2.8% | 1.9 | |
| Assay | Contain (C22H25CIN2O8) is 95.0-102.0% | 98.1 | |