Each composition per syringe: Enoxaparin Sodium USP 20/40/60/80 mg and Water for Injection USP q.s. to 0.2/0.4/0.6/0.8 ml.
It is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5.
Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains an 1,6 anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is: <2000 daltons ≤20%, 2000 to 8000 ≥68%, >8000 daltons ≤18%.
The mass-average relative molecular mass ranges between 3800 and 5000. The mass percentage of chains lower than 2000 ranges between 12.0 percent and 20.0 percent. The mass percentage of chains between 2000 and 8000 ranges between 68.0 percent and 82.0 percent.
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.
Enoxaparin sodium is available as white or almost white powder, hygroscopic.
Enoxaparin sodium injection is available as a clear, colourless to pale yellow solution and free from any visible particles.
Excipients/Inactive Ingredients: Water for injection USP.