| Product name |
Doxycycline hyclate
|
| tem | Specification |
| Characteristics | Yellow crystalline powder |
| Identification |
a) HPLC results
b) TLC results c) Color reaction with sulfuric acid d) Color reaction with silver nitrate |
| PH | 2.03.0 |
| Specific optical rotation | -105-120 Deg. |
| Specific absorbance at 349nm | 300-335 |
| Light-absorbing impurities 490nm | 0.07 max |
| Related substances |
a) Methacycline: 2.0% max
b) 6-epidoxycycline: 2.0% max c) 4-epidoxycycline: 0.5% max d) 4-epi-6-epidoxycycline: 0.5% max e) Oxytetracycline: 0.5% max f) 2-acetyl-2-decarbamoyldoxycycline: 0.5% max g) Any other impurity: 0.5% max h) Not indentified impurities:0.1%max |
| Ethanol | 4.36.0% |
| Heavy metals | 40ppm max |
| Water | 1.42.8% |
| Sulphate ash | 0.4% max |
| Assay | 95.0%102.0% (C22H25ClN2O8) 88.0%~94.0%( C22H24N2O8) basedon anhydrous, ethanol-free substance |