SPL Set ID: 419a3566-4f67-4c8d-86e5-c00c7ec429e1

Enoxaparin sodium injection 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 daltons ≥68% >8000 daltons ≤18% STRUCTURAL FORMULA * X = Percent of polysaccharide chain containing 1,6 anhydro derivative on the reducing end. R X*= 15 to 25% n= 0 to 20 100 - X H n =1 to 21 Enoxaparin sodium injection 100 mg per mL concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin sodium injection 150 mg per mL concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The enoxaparin sodium injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration ( 2 ) and How Supplied/Storage and Handling ( 16 )] . Figure Figure