DEFINITION

Dalteparin Sodium is the sodium salt of a low molecular weight heparin obtained by nitrous acid depolymerization of heparin from porcine intestine or intestinal mucosa. Heparin source material used in the manufacture of Dalteparin Sodium complies with the compendial requirements stated in the Heparin Sodium monograph. Dalteparin Sodium is produced by a validated manufacturing and purification procedure under conditions shown to minimize the presence of species containing the N–NO group. The majority of the components have a 2-O-sulfo-α-L-idopyranosuronic acid structure at the non-reducing end and a 6-O-sulfo-2,5-anhydro-D-mannitol structure at the reducing end of their chains. The weight-average molecular weight (M _w ) ranges between 5600 Da and 6400 Da, with a characteristic value of about 6000 Da. The percentage of chains lower than molecular weight 3000 Da is NMT 13.0%, and the percentage of chains higher than molecular weight 8000 Da ranges between 15.0% and 25.0%. The degree of sulfation is NLT 1.8/disaccharide unit. The potency is NLT 110 and NMT 210 Anti-Factor X_a International Units (IU)/mg of activity, calculated on the dried basis. The anti-factor IIa activity is NLT 35 IU/mg and NMT 100 IU/mg, calculated on the dried basis. The ratio of anti-factor Xa activity to anti-factor IIa activity is between 1.9 and 3.2.