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Definition: It 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. Enoxaparin consists of a complex set of oligosaccharides that have not yet been completely characterized. Based on current knowledge, the majority of the components have a 4-enopyranose urinate structure at the non-reducing end of their chain. 15 per cent to 25 per cent of the components have a 1,6-anhydro structure at the reducing end of their chain.

The mass-average relative molecular mass ranges between 3800 and 5000, 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 the dried substance. The ratio of anti-factor Xa activity to anti-factor IIa activity is between 3.3 and 5.3.

 

Quality Standard: EP7.0, BP2007,USP 33

 

Package: Packed in inclusive aluminium with double inner polybag. The outside package is a carton and size is 5kg/ carton.