Dextrose and Sodium Chloride Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Dextrose and Sodium Chloride Injection is a sterile solution of Dextrose and Sodium Chloride in Water for Injection. It contains NLT 95.0% and NMT 105.0% of the labeled amount of dextrose (C6H12O6 · H2O) and of sodium chloride (NaCl). It 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.
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2.2 B. Sodium: The sample imparts an intense yellow color to a nonluminous flame.
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2.3 C.Identification Tests-General 〈191〉, Chemical Identification Tests, Chloride: Meets the requirements
3 ASSAY
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3.1 Dextrose
Sample solution: Nominally 2-5 g of dextrose per 100 mL, 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% dextrose 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/Cu) × (Mr1/Mr2) × 100
a = observed angular rotation of the Sample solution (°)
l = length of the polarimeter tube (dm)
α = midpoint of the specific rotation for anhydrous dextrose, 52.9°
Cu = nominal concentration of dextrose in the Sample solution (g/100 mL)
Mr1 = molecular weight of dextrose monohydrate, 198.17
Mr2 = molecular weight of anhydrous dextrose, 180.16
Acceptance criteria: 95.0%-105.0%
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3.2 Sodium Chloride
Sample solution: A volume of Injection equivalent to 1.5-110 mg of sodium chloride. Add NLT 0.2 mL of diluted nitric acid and 35-100 mL of water. [Note-A protective colloid, such as polyvinyl alcohol, may be added to avoid coagulation of the silver chloride precipitate.]
Titrimetric system
- (See Titrimetry 〈541〉.)
- Mode: Direct titration
- Titrant: 0.1 N silver nitrate VS
- Endpoint detection: Potentiometric
Analysis
Sample: Sample solution
Titrate, with stirring, with Titrant and determine the endpoint potentiometrically.
Calculate the percentage of the labeled amount of sodium chloride (NaCl) in the portion of Injection taken:
Result = V × N × (F/W) × 100
V = volume of Titrant consumed by the Sample solution (mL)
N = actual normality of the Titrant (mEq/mL)
F = equivalency factor, 58.44 mg/mEq
W = nominal amount of sodium chloride in the Sample solution (mg)
Acceptance criteria: 95.0%–105.0%
4 IMPURITIES
4.1 Limit of 5-Hydroxymethylfurfural and Related Substances
Sample solution: Nominally 2 mg/mL of dextrose (C6H12O6 · H2O) prepared from a volume of Injection containing the equivalent of 1.0 g of dextrose and 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
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pH 〈791〉
- Sample solution: Nominally, 5% dextrose prepared by diluting, if necessary, a suitable volume of Injection with water
- Acceptance criteria: 3.2–6.5
Bacterial Endotoxins Test 〈85〉: It contains NMT 10.0 USP Endotoxin Units/g of dextrose.
Other Requirements: It meets the requirements in Injections and Implanted Drug Products 〈1〉.
6 ADDITIONAL REQUIREMENTS
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Packaging and Storage: Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass. Protect from freezing. Store at controlled room temperature.
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Labeling: Label to indicate 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, alternatively label to indicate the total osmolar concentration in mOsmol/mL.
