ENOXAPARIN SODIUM
Enoxaparinum natrium

Definition:
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-enopyanose uronate structure at the non-reducing end of their chain.
Enoxaparin sodium complies with the monograph on Heparin, Low-molecular-mass with the modification and additional requirements below.
Average molecular:
The mass-average molecular mass ranges between 3500 and 5500 with a characteristic value of about 4500.
The degree of sulphatation is about 2 per disaccharide unit.
The potency is not less than 90 IU and not more than 125 IU of anti-factor Xa activity per milligram, calculated with reference to dried substance. The ratio of anti-factor Xa activity to anti-factor?an activity is between 3.3 and 5.3.

Identification:
The mass-average molecular of chains lower than 2000 ranges between 12.0 per cent and 20.0 per cent. The mass percentage of chains between 2000 and 8000 ranges between 68.0 per cent and 88.0 per cent.

Test:
Appearance of solution: Dissolve 1.0g in 10ml of water R. The solution is clear and not more intensely colored than intensity 5 of the range of the range of reference solution s of the most appropriate color.
Absorbance: Dissolve 50.0mg in 100ml of 0.01M hydrochloric acid. The specific absorbance at 231nm is 14.0 to 20.0, calculated with reference to dried substance.
Benzyl alcohol. Not more than 0.1 per cent m/m, determined by liquid chromatography.
Sodium: 11.3 to 13.5 per cent of Na calculated with reference to dried substance and by atomic absorption spectrometry.

ENOXAPARIN SODIUM INJECTION

Reference Concentration:
1. 100mg per ml:
Pre-filled sryinges:30mg/0.3ml, 40mg/0.4ml, 50mg/0.5ml
ampules: 30mg/0.3ml, 40mg/0.4ml, 50mg/0.5ml
2. 150mg per ml:
Pre-filled syringes: 120mg/0.8ml, 150mg/1ml

Clinical Applications:
It is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism;
It is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
It is indicated for
-the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium;
-the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.

Contraindications:
It is contraindicated in patients with active major bleeding, in patients with thrombocytopenia associated with a positive in vitro test for anti- platelet antibody in the presence of enoxaparin sodium, or in patients with hypersensitivity to enoxaparin sodium.
Patients with known hypersensitivity to heparin, or pork products should not be treated with enoxaparin sodium injection or any of its constituents.