DEFINITION

Enoxaparin Sodium is the sodium salt of a depolymerized heparin. It is obtained by alkaline depolymerization of heparin benzyl ester. The starting material, heparin, is obtained exclusively from porcine intestinal mucosa. Heparin source material used in the manufacture of Enoxaparin Sodium complies with the compendial requirements stated in the Heparin Sodium monograph. Enoxaparin Sodium consists of a complex set of oligosaccharides that have not yet been completely characterized. The majority of the components have a 4-enopyranose uronate structure at the nonreducing end of their chain. About 20% of the materials contain a 1,6-anhydro derivative on the reducing end of the chain, the range being between 15% and 25%. The weight-average molecular weight of Enoxaparin Sodium is 4500 Da, the range being between 3800 and 5000 Da; about 16% have a molecular weight of less than 2000 Da, the range being between 12.0% and 20.0%; about 74% have a molecular weight between 2000 and 8000 Da, the range being between 68.0% and 82.0%. NMT 18.0% have a molecular weight higher than 8000 Da. When prepared as a solution, the solution is analyzed for clarity and degree of color using a validated method. The degree of sulfation is NLT 1.8 per disaccharide unit. It has a potency of NLT 90 and NMT 125 Anti-Factor Xa International Units (IU)/mg, and NLT 20.0 and NMT 35.0 Anti-Factor IIa IU/mg, calculated on the dried basis. The ratio of Anti-Factor Xa activity to Anti-Factor IIa activity is between 3.3 and 5.3.