SPL Set ID: 0332f34a-7038-47cc-ba59-d55cad6b73ca

Dextrose Injection 70%, USP is a clear, sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in Water for Injection in a flexible plastic container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program. Dextrose Injection is not for direct intravenous infusion [see Dosage and Administration (2.1) ] . The Pharmacy Bulk Package is designed to facilitate admixture or dilution to provide dextrose in various concentrations and is available in a 2000 mL size. See Table 1 for the content and characteristics of this solution. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use following admixture or dilution. The pH range is 4.0 (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 70%, USP Strength Fill Volume Amount of Dextrose Hydrous, USP per container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous per Container Osmolarity (mOsmol per liter) (calc.) Dextrose Injection 70%, USP (0.7 grams/mL) 2000 mL 1400 grams 4760 3530 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: Water for Injection, USP is chemically designated H 2 O. Dextrose Injection 70%, USP contains no more than 25 mcg/L of aluminum. Dextrose is derived from corn. Structural formula of Dextrose Hydrous, USP