It is mainly indicated for the prophylaxis of Deep Venous Thrombosis (DVT) and pulmonary embolism, treatment of venous thrombosis, prevention of clotting during hemodialysis, treatment of unstable angina and non-Q-wave myocardial infarction.
Haoran Biopharma can supply bulk Enoxaparin Sodium with the following specifications. Products of various specifications can also be prepared according to customers' requests.
|
Appearance |
White or almost white powder, hygroscopic |
|
Solubility |
Freely soluble in water |
|
Identification |
A. The spectrum obtained is similar to enoxaparin sodium CRS
B. The ratio of Anti-factor Xa activity to anti-factor IIa activity: 3.3-5.3
The mass-average relative molecular mass ranges between 3800 and 5000
C. The mass percentage of chains lower than 2000：12.0%～20.0%
The mass percentage of chains between 2000 and 8000: 68.0%～82.0%
D. It gives reaction (a) of sodium |
|
Appearance of solution (10% solution w/v) |
The solution is clear and not more intensely coloured than intensity 6 of the range of reference solutions of the most appropriate colour |
|
pH (10% W/V solution) |
6.2～7.7 |
|
Specific absorbance (dried substance) |
14.0～20.0 |
|
Nitrogen (dried substance) |
1.5%～2.5% |
|
Sodium (dried substance) |
11.3%～13.5% |
|
Heavy metals |
≤30ppm |
|
Loss on drying |
≤10.0% |
|
Molar ratio of sulfate ions to carboxylate ions |
≥1.8 |
|
Bacterial endotoxins |
N.M.T. 0.01 EU/1 IU anti-factor Xa activity |
|
Assay (dried substance) |
Anti-factor Xa activity: 90 IU-125 IU/mg
Anti-factor IIa activity: 20 IU-35 IU/mg
The ratio of anti-factor Xa activity to anti-factor IIa activity: 3.3～5.3 |
|
Benzyl alcohol |
≤0.1% (m/m) |
|
Residual ethanol |
≤5000 ppm |
|
Microbial enumeration tests |
Total aerobic microbial count: ≤1000cfu/g
Total combined yeast/moulds count: 100cfu/g |
|
Test for specified micro-organisms |
Escherichia coli: not detected/g |
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