Enoxaparin Sodium
CAS No.: 679809-58-6 (Low molecular weight heparin)

Short Description:

Source: Extracted from porcine intestinal mucosa and degraded by β-elimination method.

Function and use: By inhibiting coagulation active factor X (FXa) and thrombin (FIIa), heparin pentose structure binds AT-III (antithrombin III), and exerts anticoagulant effect.
Enoxaparin sodium prevents venous thromboembolic disease (prevention of thrombosis in the veins), especially those associated with orthopaedic or general surgery; treats established deep vein thrombosis, with or without pulmonary embolism, clinical Symptoms are not severe, excluding pulmonary embolism requiring surgery or thrombolytic therapy; treatment of unstable angina pectoris and non-Q-wave myocardial infarction, in combination with aspirin; used in hemodialysis cardiopulmonary bypass to prevent thrombosis; treatment of acute ST segment Elevated myocardial infarction, combined with thrombolytics or concurrently with percutaneous coronary intervention (PCI).

Enoxaparin Sodium-Pharmacopoeia Standard: BP/EP

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Specification

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 chain15%- 25 % of components bearing the 1,6-anhydro structure at the reducing end of their chain
			Anti-factor Xa activity/ anti-factor IIa : 3.3-5.3	Anti-factor Xa activity/ anti-factor IIa : 3.3-5.3
			Mw : 3800 -5000Da, M_≤2000 : 12.0%-20.0%, M_≥8000:NMT 18.0%, M_2000-8000:68.0%-82.0%	Mw : 3800 -5000Da, M_≤2000 :12.0%-20.0%, M_2000-8000:68.0%-82.0%
			Meets the requirements for Sodium chemical identification tests	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- factor Xa activity		90-125 IU/mg (on the dried basis)	90-125 IU/mg (on the dried basis)
	Anti- factor IIa activity		20.0-35.0 IU/mg (on the dried basis)	20.0-35.0 IU/mg (on the dried basis)

Indication

1. Prevention of venous thromboembolic diseases (prevention of venous thrombosis), especially in relation to orthopaedic or general surgery

2. Treatment of existing deep vein embolism, with or without pulmonary embolism, with mild clinical symptoms, excluding pulmonary embolism requiring surgery or thrombolytic therapy.

3. Treatment of unstable angina pectoris and non-Q wave myocardial infarction, combined with aspirin.

4. Used in cardiopulmonary bypass for hemodialysis to prevent thrombosis.

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CAS No.: 9041-08-1 (Low molecular weight heparin)

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