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Doxycycline Hydrochloride
| ITEMS | LIMIT |
| Appearance | Yellow crystalline powder, hygroscopic |
| Solubility | Freely soluble in water and in methanol, sparingly |
| soluble in alcohol, practically insoluble in ether. It dissolves in solutions of alkali hydroxides and carbonates | |
| Identification | |
| IR | The IR spectrum of sample should be the same as that of Reference Standard Doxycycline Hyclate. |
| Crystallinity | Crystals |
| pH | 2.0 ~ 3.0 |
| Water | 1.4% ~ 2.8% |
| Related substances | |
| a) 6-Epidoxycycline | ≤2.0% |
| b) Methacycline | ≤2.0% |
| c) 4-epidoxycycline | ≤0.5% |
| d) 4-epi-6-epidoxycycline | ≤0.5% |
| e) Oxytetracycline | ≤0.5% |
| f) 2-acetyl-2-decarbamoyldoxycycline | ≤0.5% |
| g) Any other impurity | ≤0.5% |
| Ethanol | 4.3% ~ 6.0% |
| Assay | 95.0%~102.0%(C22H25CIN2O8),anhydrous,ethanol free |
| Potency | 800-920 μg/mg (C22H24N2O8) , as is |
| Heavy Metals | ≤50ppm |
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