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Enoxaparin Sodium

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Enoxaparin Sodium
Enoxaparin sodium is the sodium salt of a low-molecular-mass heparin that is obtained by alkaline depolymerisation of the benzyl ester derivative of heparin from porcine intestinal mucosa. The majority of the components have a 4-enopyranose uronate structure at the nonreducing end of their chain

 

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