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Description
11 DESCRIPTION
Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), 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 H2O.
Dextrose Injection, USP (5%) is a clear, sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single-dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1)].
Partial-fill containers, designed to facilitate admixture, are available in 50 mL, 100 mL, and 250 mL sizes. See Table 1 for the content and characteristics of this solution.
The solution contains no bacteriostatic, antimicrobial agent or added buffer and is supplied as single-dose containers. The pH is 4.3 (range is 3.2 to 6.5).
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Strength | Fill Volume | Amount of Dextrose Hydrous per Container | kcal* per Container | mOsmol per Liter |
5% Dextrose | 50 mL | 2.5 grams | 8.5 | 253 |
100 mL | 5 grams | 17 | 253 | |
250 mL | 12.5 grams | 42.5 | 253 | |
Dextrose is derived from corn.
Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
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