Product Name		Enoxaparin sodium	Grade	Injectable
According to		EP 9.0
Items		Standards	Results
Characters		A white or almost white powder	Almost white powder
Solubility		Freely soluble in water	Complies
Identification	Examine by nuclear magnetic resonance spectrometry	The spectrum obtained with the test solution is similar to specific low-molecular-mass heparin CRS.	Complies
	1,6-anhydro derivatives	15%-25%	23.0%
	The ratio of anti-factor Xa activity to anti-factor II a activity	3.3-5.3	4.8
	Molecular distribution	`Mw:3800-5000 <2000:12.0%-20.0% 2000-8000:68.0%-82.0%	4633 17.8% 70.1%
	Reaction of sodium	It gives reaction of sodium	Complies
Appearance of solution		Clear and not more than intensity 6	Complies
PH		6.2-7.7	6.9
Nitrogen		1.5%-2.5%(Dry)	2.0%
Heavy metals		≤30ppm	<30ppm
Luminous absortion		14.0-20.0	17.0
Benzyl alcohol		≤0.1%(m/m)	0.01%
Sodium		11.3%-13.5%(Dry)	12.3%
Residual solvent		Ethanol:≤5000ppm Methanol:≤3000ppm Dichloromethane:≤600ppm	4000ppm 40ppm Not detectable
Molar ratio of sulphate ions to carboxylate ions		≥1.8	2.1
Loss on drying		≤10.0%	0.9%
Bacterial endotoxin		≤0.01 EU/A Xa IU	<0.01 EU/A Xa IU
Microbiological examination		Total viable aerobic count:≤100cfu/g Fungi count:≤10cfu/g No pathogenic microorganisms(Escherichiacoil,Staphylococcus Aureus,Salmonella Species,Pseudomonas Aeruginosa,Bile-Tolerant Gram-Negative Bacteria)	<10cfu/g <10cfu/g Not detectable
Anti-factor II a activity		20 IU/mg-35IU/mg(Dry)	25IU/mg(wet 25 IU/mg)
Anti-factor Xa activity		90IU/mg-125IU/mg(Dry)	119IU/mg(wet 118 IU/mg)

Enoxaparin Sodium CAS No 679809-58-6

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