SPL Set ID: 0d929726-76c3-48fc-b4e7-fd06409f9fb3

Heparin is a heterogenous 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. Heparin Sodium in Sodium Chloride Injection is a buffered, sterile, nonpyrogenic solution of Heparin Sodium, USP derived from porcine intestinal mucosa, standardized for anticoagulant activity supplied in single dose containers for vascular administration. It contains no antimicrobial agents. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Composition, osmolarity, pH and ionic concentration are shown in Table 1. Table 1. Composition, Osmolarity, pH, and Ionic Concentration of Heparin in 0.9% Sodium Chloride Injection Product Description and Size 1,000 USP Heparin Units in 0.9% Sodium Chloride Injection, 500 mL 1,000 USP Heparin Units in 0.9% Sodium Chloride Injection, 500 mL 2,000 USP Heparin Units in 0.9% Sodium Chloride Injection, 1,000 mL 2,000 USP Heparin Units in 0.9% Sodium Chloride Injection, 1,000 mL NDC# 0338-0431-03 0338-0424-18 0338-0433-04 0338-0428-12 Manufacturing Location Jayuya, PR Toongabbie, AUS Jayuya, PR Toongabbie, AUS Heparin Sodium, USP (units/mL) 2 2 2 2 Sodium Chloride, USP (NaCl) (g/L) 9 9 9 9 Dibasic Sodium Phosphate Heptahydrate, USP (Na 2 HPO 4 *7H 2 O) (g/L) 4.34 ---- 4.34 ---- Dibasic Sodium Phosphate Dodecahydrate, USP (Na 2 HPO 4 *12H 2 O) (g/L) ---- 5.80 ---- 5.80 Citric Acid Hydrous, USP (C 6 H 8 O 7 *H 2 O) (g/L) 0.4 0.4 0.4 0.4 Osmolarity Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. (mOsmol/L) 322 322 322 322 pH 7.0 (6.0 to 8.0) 7.0 (6.0 to 8.0) 7.0 (6.0 to 8.0) 7.0 (6.0 to 8.0) Sodium (mEq/L) 186 186 186 186 Chloride (mEq/L) 154 154 154 154 Phosphate (as HPO 4 = ) (mEq/L) 32 (16 mmol/L) 32 (16 mmol/L) 32 (16 mmol/L) 32 (16 mmol/L) Citrate (mEq/L) 6 6 6 6 This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX PLUS on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX PLUS plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g ., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Heparin Sodium Structural Formula