Heparin Sodium Injection - Pharmaceutical Information, Clinical Trials, Detailed Pharmacology, Toxicology
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Heparin Sodium Injection - Scientific Information

Manufacture: Fresenius Kabi USA, LLC
Country: Canada
Condition: Thromboembolic Disorder, Thromboembolism (Deep Vein Thrombosis), Thrombotic/Thromboembolic Disorder
Class: Anticoagulants
Ingredients: Heparin Sodium

Pharmaceutical Information

Drug Substance

Proper Name: Heparin Sodium
CAS No.: 9041-08-1
Structural Formula:
Description:

Heparin is a heterogeneous group of straight-chain anionic mucopolysaccarides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin sodium is derived from porcine intestinal mucosa, standardized for anticoagulant activity.

Stability and Storage Recommendations

Store Heparin Sodium Injection, USP vial between 15 and 30°C. Protect from freezing. For multiple-dose vials, discard unused portion 28 days after initial puncture. For single-dose vials, discard unused portion.

Availability of Dosage Forms

Heparin Sodium Injection, USP is supplied in the following concentrations and package sizes.

Vial stoppers do not contain natural rubber latex.

C504701 Heparin 1,000 USP Units/mL in 1 mL multiple-dose vial in package of 25 vials. Also contains methylparaben 1.5 mg/mL, propylparaben 0.15 mg/mL, sodium chloride 9 mg/mL for isotonicity, and q.s. to 1 mL with Water for Injection. Porcine intestinal mucosa origin.
C504710 Heparin 1,000 USP Units/mL in 10 mL multiple-dose vial in package of 25 vials. Also contains methylparaben 1.5 mg/mL, propylparaben 0.15 mg/mL, sodium chloride 9 mg/mL for isotonicity, and q.s. to 10 mL with Water for Injection. Porcine intestinal mucosa origin.
C504730 Heparin 1,000 USP Units/mL in 30 mL multiple-dose vial in package of 25 vials. Also contains methylparaben 1.5 mg/mL, propylparaben 0.15 mg/mL, sodium chloride 9 mg/mL for isotonicity, and q.s. to 30 mL with Water for Injection. Porcine intestinal mucosa origin.
C504801 Heparin 10,000 USP Units/mL in 1 mL multiple-dose vial in package of 25 vials. Also contains methylparaben 1.5 mg/mL, propylparaben 0.15 mg/mL, and q.s. to 1 mL with Water for Injection. Porcine intestinal mucosa origin.
C504805 Heparin 10,000 USP Units/mL in 5 mL multiple-dose vial in package of 25 vials. Also contains methylparaben 1.5 mg/mL, propylparaben 0.15 mg/mL, and q.s. to 5 mL with Water for Injection. Porcine intestinal mucosa origin.
C504301 Heparin 10,000 USP Units/mL 0.5 mL fill in 2 mL single-dose vial in package of 25 vials. Preservative free. Also contains Water for Injection q.s. Porcine intestinal mucosa origin.

Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to use.


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