Dextrose Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Dextrose Injection is a sterile solution of Dextrose in Water for Injection. It contains NLT 95.0% and NMT 105.0% of the labeled amount of dextrose (C₆H₁₂O₆·H₂O). Dextrose Injection contains no antimicrobial agents.

2 IDENTIFICATION

2.1 A.

Sample solution: Nominally 50 mg/mL of dextrose from a suitable volume of Injection in water

Analysis: Add a few drops of the Sample solution to 5 mL of hot alkaline cupric tartrate TS.

Acceptance criteria: A copious red precipitate of cuprous oxide is formed.

3 ASSAY

Change to read:

3.1 Procedure

Sample solution: Nominally 20–50 mg/mL of dextrose prepared as follows. Transfer a volume of Injection containing 2–5 g of dextrose to a 100-mL volumetric flask. Add 0.2 mL of 6 N ammonium hydroxide, and dilute with water to volume.

[Note-Ammonium hydroxide may be omitted for finished products containing up to 10% of dextrose and that have been terminally heat sterilized.]

Analysis

Sample: Sample solution

Determine the angular rotation in a suitable polarimeter tube (see Optical Rotation 〈781〉).

Calculate the percentage of the labeled amount of dextrose (C₆H₁₂O₆·H₂O) in the portion of Injection taken:

Result = [(100 × a)/(l × α)] × (1/C_u) × (M_r1/M_r2) × 100

a = observed angular rotation of the Sample solution (°)

l = length of the polarimeter tube (dm)

α = midpoint of the specific rotation range for anhydrous dextrose, 52.9°

C_u = nominal concentration of dextrose in the Sample solution (g/100 mL)

M_r1 = molecular weight of dextrose monohydrate, 198.17

M_r2 = molecular weight of anhydrous dextrose, 180.16

Acceptance criteria: 95.0%–105.0%

4 IMPURITIES

4.1 Limit of 5-Hydroxymethylfurfural and Related Substances

Sample solution: Nominally 4 mg/mL of dextrose (C₆H₁₂O₆·H₂O) from a volume of Injection equivalent to 1.0 g of dextrose in water

Instrumental conditions

• Mode: UV
• Analytical wavelength: 284 nm
• Cell: 1 cm
• Blank: Water

Analysis

• Samples: Sample solution and Blank

Acceptance criteria: The absorbance of the Sample solution is NMT 0.25.

5 SPECIFIC TESTS

5.1 pH 〈791〉

Sample solution: Dilute a suitable volume of Injection, if necessary, with water to NMT 5% of dextrose.

Analysis: Add 0.30 mL of saturated potassium chloride to 100 mL of Sample solution, and measure the pH.

Acceptance criteria: 3.2–6.5

5.2 Particulate Matter in Injections 〈788〉

Meets the requirements

5.3 Bacterial Endotoxins Test 〈85〉

[Note-Before analysis, dilute Injections containing more than 10% of dextrose to a concentration of 10% of dextrose.]

Acceptance criteria: NMT 0.5 USP Endotoxin Units/mL for Injection containing less than 5% dextrose; NMT 10.0 USP Endotoxin Units/g for Injection containing 5%–70% dextrose

5.4 Other Requirements

It meets the requirements in Injections and Implanted Drug Products 〈1〉.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass. Store at room temperature.

Labeling: The label states the total osmolar concentration in mOsmol/L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol/mL.