11 DESCRIPTION

Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, 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, and (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.

Structure of Heparin Sodium (representative subunits):

Dextrose, USP is chemically designated D-glucose, monohydrate C6H12O6 ∙ H2O, a hexose sugar freely soluble in water. It has the following structural formula:

Water for Injection, USP is chemically designated H2O.

Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. Each 100 mL contains heparin sodium 5,000 or 10,000 USP Units; dextrose, hydrous 5 g; citric acid, anhydrous, 51 mg and sodium citrate, dihydrate 334 mg added as buffers; sodium metabisulfite 20 mg added as an antioxidant. Each liter contains electrolytes sodium and citrate in amounts as listed in HOW SUPPLIED/STORAGE AND HANDLING Table. See Table for summary of contents and characteristics of this solution. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram.

The flexible plastic container is fabricated either from a specially formulated nonplasticized, thermoplastic co-polyester (CR3) or from a polyolefin film. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.