Active Ingredients: Heparine

Sodium Heparin for Injectables

 

Description:
It is a very complex Glicosaminoglican composed by an altérnates sequence of D-glucosamine linked by a (1-4) bound  to an hexuronic acid. The hexuronic acids could be L-idurónic acid or D-glucurónic acid and the D-glucosamine could be N-acetilated or N-sulphated.
 
Uses:
It is used for two main clinical purposes :
1.Prevention of clotting and thrombus formation resulting from manipulations in the cardio-vascu­lar system (catheterisms, cardiac and arterial surgery, extracorporeal circulation, etc.) 
2.Limitation or prevention of thromboembolism after surgery, delivery and in hypercoagulable states, as well as in patients with increased tendency to thrombosis.
It is used for injectables formulations (vials or ampoulles)
 
Described in EP, USP, JP
 
Main Characteristics:
Finely ground, slightly hygroscopic, white powder obtained from intestinal mucosa or other suitable tissues of domestic animals used for food by man. It is an anticlotting agent inhibiting coagulation of blood both in vivo and in vitro.
 
Presentation:
Bulk powder in double polyethylene bag contained in lined drums.
 
Specifications according to international pharmacopeias:

SODIUM HEPARIN INJECTABLE GRADE
Appearance
White to slightly colored amorphous powder
Ident. Anticlotting activity
It delays the clotting of citrated sheep plasma
Ident. H-RMN (OSCS)
Complies
Ident. Liquid chromatog.
Complies
Sodium
Complies
Potency EP (IU/mg)
Not less than 180 UI/mg
Solubility
Freely soluble in water
Appearance of solution
Clear solution and complies with J5 colour
pH sol. 1%
5.5 – 8.0
Nucleotidic impurities (A 260 nm (sol. 0.4 %))
Not more than 0.15
Proteins (Lowry)
Not more than 0.5 %
Related substances
Complies
Nitrogen
1.5 to 2.5 %
Sodium
9.5 – 12.5 %
Heavy Metals
 Not more than 30 ppm
Loss on drying
Less than 8.0 %
Bacterial Endotoxins
Less than 0.01 UE/IU
Total aerobic count
Less than 100 CFU/g
Escherichia coli
Absence
Salmonella spp
Absence
Pseudomona Aeruginosa
Absence
Enterobacteria and certain other gram-neg bact.
Absence

 

Indications:

Anticlotting, Pharmaceutical applications

Available in this countries:

América del Sur, Argentina, Medio Oriente, Union Europea, USA