| Item | Index | Result |
| Appearance | White crystalline powder, soluble in water. It dissolves in dilute acid and alkaline solutions. | Conform |
| Identification | a) TLC results | Conform |
| b) Color reaction with sulfuric acid | Conform |
| c) Color reaction with silver nitrate | Conform |
| Ph | 4.5 to 7.0 | 6 |
| Specific optical rotation | -203°to -216°° | -206° |
| Specific absorbance at 353nm | 290 to 310 | 308 |
| 308 |
| Light-absorbing impurities | a) At 430nm not greater than 0.25 | 0.08 |
| b) At 490nm not greater than 0.20 | 0.01 |
| Related substances | 4-epioxytetracycline≤ 0.5% | 0.20% |
| Tetracycline hydrochloride≤2.0% | 0.30% |
| Peak on the tail of the main peak≤2.0% | 1.60% |
| Heavy metals | Not more than 50ppm | <50ppm |
| Water | 6.0 % to 9.0% | 7.70% |
| Sulphated ash | Not more than 0.5% | 0.03% |
| Assay | 95.0% -100.5%(C22H24N2O9) based onanhydrous substance | 99.10% |
Complaint
