SPL Set ID: b5cb7a5a-bbe8-4217-a82e-da818f7771c9

Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions . The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Table 1. Contents and Characteristics of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume Amount of Dextrose Hydrous per Container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous. per Container mOsmol per liter 20% (0.2 grams/mL) 500 mL 100 grams 340 1009 30% (0.3 grams/mL) 500 mL 150 grams 510 1514 40% (0.4 grams/mL) 500 mL 200 grams 680 2018 50% (0.5 grams/mL) 500 mL 250 grams 850 2523 70% (0.7 grams/mL) 500 mL 350 grams 1190 3532 Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula: Dextrose may be derived from corn. Water for Injection, USP is chemically designated H 2 O. Dextrose Injection contains no more than 25 mcg/L of aluminum. Structural Formula for Dextrose Injection, USP