Items tested |
Specifications |
|
Characters (01/2008:1097) |
A white or almost white powder. Hydroscopic.
Freely soluble in water |
|
Identification |
A: 13C NMR Spectrum (2.2.33) |
|
B: Anti-FXa/Anti-FIIa 3.3 to 5.3 (01/2008:0828) |
|
C: The weight-average molecular weight is 4500Da, the range being between 3800 and 5000Da
The percent has a molecular weight of less than 2000Da, the range being between 12.0% and 20.0%
The percent has molecular weight of between 2000 and 8000Da, the range being between 68.0% and 82.0% (2.2.30)
|
|
D: it gives reaction of sodium (2.3.1) |
|
1H-NMR Spectrum (2.2.33) |
The sample should be free from OSCS |
|
Appearance of solution
(2.2.1 &2.2.2 method II) |
Dissolve 1.0g in 10ml of water R, the solution is clear and not more intensely colored than intensity 6 of the range of reference solutions of the most appropriate color |
|
Specific absorbance (2.2.25) |
The specific absorbance at 231nm being between 14.0 and 20.0 (dried substance) |
|
Bacterial endotoxins (2.6.14) |
<0.01IU/Anti-FXa IU activity |
|
pH at a concentration of 10%
(2.3.3) |
6.2 to7.7 |
|
Loss on drying (2.3.2) |
≤10.0% |
|
Nitrogen (2.5.9) |
1.5% to 2.5% |
|
Heavy metals (2.4.8) |
≤30ppm |
|
Sodium content
(2.3.23 method I) |
11.3% to 13.5% |
|
SO42-/COO- (01/2008:0828) |
≥1.8 |
|
Benzyl alcohol
(01/2008:1097 & 2.2.29) |
≤0.1%(m/m) |
|
Limit of residual solvents CH2Cl2 (2.3.28) |
≤600ppm |
|
Methanol (2.3.28) |
≤3000ppm |
|
Anti-FXa (01/2008:0828) |
90 IU to 125 IU/mg |
|
Anti-FIIa (01/2008:0828) |
20 IU to 35 IU/mg |
|
1,6-anhydro derivative
USP/NF Supplement <207> |
15.0~25.0% |
|
Conclusion |
Complies with the requirements of EP7.0 |