DESCRIPTION---Innohep®
INNOHEP is a sterile solution, containing tinzaparin sodium, a low molecular weight heparin. It is available in a multiple dose 2 mL vial.
Each 2 mL vial contains 20,000 anti-Factor Xa IU (anti-Xa) of tinzaparin sodium per mL, for a total of 40,000 IU, and 3.1 mg/mL sodium metabisulfite as a stabilizer. The vial contains 10 mg/mL benzyl alcohol as a preservative. Sodium hydroxide may be added to achieve a pH range of 5.0 to 7.5.
Table 1
Composition of 20,000 anti-Xa IU/mL INNOHEP
(tinzaparin sodium injection)
|
Component |
Quantity per mL |
|
Tinzaparin sodium |
20,000 anti-Xa IU |
|
Benzyl alcohol, USP |
10 mg |
|
Sodium metabisulfite, USP |
3.106 mg 1 |
|
Sodium hydroxide, USP |
as necessary |
|
Water for Injection, USP |
q.s. to 1 mL |
|
1 Corresponding to 3.4 mg/mL sodium bisulfite |
Tinzaparin sodium is the sodium salt of a low molecular weight heparin obtained by controlled enzymatic depolymerization of heparin from porcine intestinal mucosa using heparinase from Flavobacterium heparinum . The majority of the components have a 2-O-sulpho-4-enepyranosuronic acid structure at the non-reducing end and a 2-N,6-O-disulpho-D-glucosamine structure at the reducing end of the chain.
Potency is determined by means of a biological assay and interpreted by the first International Low Molecular Weight Heparin Standard as units of anti-factor Xa (anti-Xa) activity per milligram. The mean tinzaparin sodium anti-factor Xa activity is approximately 100 IU per milligram. The average molecular weight ranges between 5,500 and 7,500 daltons. The molecular weight distribution is:
|
<2,000 Daltons <10%
2,000 to 8,000 Daltons 60% to 72%
>8,000 Daltons 22% to 36% |
|
