Dalteparin Sodium

Description:
It is the sodium salt of a low-molecular-mass heparin that is obtained by nitrous acid depolymerisation of heparin from porcine intestinal mucosa. The majority of the components have a 2-O-sulpho-a-L-idopyranosuronic acid structure at the non-reducing end and a 6-O-sulpho-2,5-anhydro-D-mannitol structure at the reducing end of their chain.
The mass-average molecular mass ranges between 5600 and 6400, with a characteristic value of about 6000. The degree of sulphatation is 2.0 to 2.5 per disaccharide unit. The potency is not less than 110IU and not more than 210 IU of anti-factor Xa activity per milligram, calculated with reference to the dried substance. The anti-factor IIa activity is not less than 35IU and not more than 100 IU/mg, calculated with reference to the dried substance. The ratio of anti-factor Xa activity to anti-factor IIa activity is between 1.9 and 3.2.
Quality Standard: EP6.0, BP2007