| Enoxaparin Sodium | ||||
| Source | Intestinal mucosa of pigs | |||
| Quality standard |
USP |
EP |
||
|
characters |
Appearance |
/ |
white or almost white; hygroscopic powder | |
| solubility |
/ |
freely soluble in water | ||
| identification | The spectra exhibit maxima at 231±2nm | The 13C NMR spectrum obtained is similar to that obtained with the appropriate specific Enoxaparin sodium CRS | ||
| The spectra are similar | 15 -25 % bearing the 1,6-anhydro structure at the reducing end of their chain | |||
| Anti- Xa activity/ anti- IIa : 3.3-5.3 | Anti- Xa activity/ anti- IIa : 3.3-5.3 | |||
| Mw : 3800 -5000Da, M≤2000 : 12.0%-20.0%, M≥8000:NMT 18.0%, M2000-8000:68.0%-82.0% | Mw : 3800 -5000Da, M≤2000 : 12.0%-20.0%, M≥8000:NMT 18.0%, M2000-8000:68.0%-82.0% | |||
| Meets the requirements for Sodium Content | It complies with the test for sodium | |||
| Appearance of solution | / | clear；NMT: intensity 6 | ||
| Specific Absorbance | 14.0-20.0 (on the dried basis) | 14.0-20.0 (on the dried basis),determined at 231nm | ||
| pH | 6.2-7.7 | 6.2-7.7 | ||
| Benzyl alcohol | ≤ 0.1% | ≤ 0.1% | ||
| Molar ratio of Sulfate carboxylate | ≥ 1.8 | ≥ 1.8 | ||
| Nitrogen | 1.8 %-2.5 % (on the dried basis) | 1.5 %-2.5 % (on the dried basis) | ||
| Sodium | 11.3% -13.5% (on the dried basis) | 11.3% -13.5% (on the dried basis) | ||
| Loss on drying | ≤ 10.0% | ≤ 10.0% | ||
| Bacterial endotoxins | ＜0.01EU/U | ＜0.01EU/IU | ||
| Assay | Anti- Xa activity | 90-125 IU/mg (on the dried basis) | 90-125 IU/mg (on the dried basis) | |
| Anti- IIa activity | 20-35 IU/mg (on the dried basis) | 20-35 IU/mg (on the dried basis) | ||