CAS number： 64-72-2
Molecular formula： C22H24Cl2N2O8
molecular weight： 515.3406
Chemical structure：
| PRODUCT NAME | CHLORTETRACYCLINE HCL | |
| SPECIFICATIONS | EP8.0 | |
| TESTS | SPECIFICATIONS | RESULTS |
| Appearance | Yellow powder | Conforms |
| Identification | ||
| A ( Current Ph. Eur. 2.2.27) | Thin·Layer Chromatography | Positive |
| B(Current Ph. Eur. 0173) | The colour becomes brownish | Positive |
| C(Current Ph. Eur. 2.3.1) | It gives reaction (a) of chlorides | Positive |
| D(Current Ph. Eur. 2.2.29) | Liquid chromatography | Positive |
| pH (Current Ph. Eur. 2.2.3 | 2.3-3.3 | 2.69 |
| Specific Optica Irotation (CurrentPh.Eur.2.2.7) | 250° to 235°(anhydrous substance) | 249° |
| Absorbance (Current Ph. Eur. 2.2.25) | ≤0.40, 460nm | 0.202 |
| Related substances (Current Ph. Eur. 2.2.29) | ||
| Impurity A (4-epichlortetracycline) | ≤4.0% | 0.82% |
| Impurities E(4-epidemethylchlortetracycline) | ≤1.0% | 0.65% |
| Impurity J (anhydrotetracycline) | ≤0.3% | 0.08% |
| Impurities D(4-epitetracycline) | ≤0.2% | <0.05%< td=""> |
| Impurities G(isochlortetracycline) | ≤0.2% | Not detected |
| Impurities H(2-acetyl-2 -decarboxamidochlortetracycline) | ≤0.2% | 0.12% |
| Impurities L(anhydrochlortetracycline) | ≤0.2% | 0.11% |
| Impurities K(4-epianhydrochlortetracycline) | ≤0.15% | Not detected |
| Unspecified impurities | ||
| Impurities C(4-epidemethyltetracycline) | ≤0.10% | Not detected |
| Impurities F(4-epiisochlortetracycline) | ≤0.10% | Not detected |
| Impurities I (4-epianhydrotetracycline) | ≤0.10% | Not detected |
| Disregard limit (Other Unknown) | ≤0.05% | Conforms |
| Sum of impurities other than A | ≤2.0% | 1.12% |
| Heavy metals (Current Ph. Eur. 2.4.8) | ≤50ppm | <50ppm< td=""> |
| Water (Current Ph. Eur. 2.5.12) | ≤2.0% | 0.54% |
| Sulfated ash (Current Ph. Eur. 2.4.14) | ≤0.5% | 0.14% |
| ASSAY (Current Ph. Eur. 2.2.29) | ||
| Chlortetracycline hydrochloride (CTC.HCI) | ≤89.5% (anhydrous substance) | 91.76% |
| Tetracycline hydrochloride (TC.HCI) | ≤6.0% (anhydrous substance) | 5.86% |
| CTC.HCI+TC.HCI | 94.5-102,0%(anhydrous substance) | 97.62% |
| Ethanol (SOP) | ≤0.5%(GC) | 0.41% |
