Dextran 70 in 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 

Dextran 70 in Dextrose Injection is a sterile solution of Dextran 70 and Dextrose in Water for Injection. It contains in each 100 mL NLT 9.0 g and NMT 11.0 g of Dextran 70 and NLT 4.5 g and NMT 5.5 g of dextrose monohydrate (C₆H₁₂O₆ . H₂O). It contains no bacteriostatic agents. 

2 IDENTIFICATION 

2.1 A. 

Diluent: Dextrose (4.5 in 100) 

Sample solution: Injection, diluted with Diluent to 10 mg/mL of dextran 70 

Analysis: Using a capillary tube viscometer having dimensions such that the ow time of water is NLT 100 s, measure the ow times of the Diluent and of the Sample solution at 20°. 

Calculate the intrinsic viscosity: 

Result = {ln[R_D × (t/t₀)]}/C 

R_D = ratio of the density of the Sample solution to that of the Diluent 

t = ow time of the Sample solution 

t₀ = ow time of the Diluent  

C = concentration of dextran 70 in the Sample solution (g/mL) 

Acceptance criteria: 24–29 mL/g 

3 ASSAY 

3.1 Dextrose 

Mobile phase: 0.01 N sulfuric acid, ltered and degassed 

System suitability solution: 5 mg/mL each of dextrose and Xylitol in water 

Standard solution: USP Dextrose RS, diluted to 5 mg/mL of dextrose monohydrate in water 

Sample solution: 10 mL of Injection in 25 mL of water 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: Refractive index 

Column: 7.8-mm × 30-cm; packing L17 

Temperatures: Column and, if necessary, detector are maintained at a constant temperature of about 40°. 

Flow rate: 0.6 mL/min 

Injection volume: 50 µL 

System suitability 

Samples: System suitability solution and Standard solution 

Suitability requirements 

Resolution: NLT 2.5 between the dextrose and xylitol peaks, System suitability solution 

Relative standard deviation: NMT 1.5% for dextrose, Standard solution 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the concentration of dextrose monohydrate (C₆H₁₂O₆ . H₂O), in g/100 mL, in the volume of Injection taken: 

Result = (r_u/r_s) × C × D × (M_r1/M_r2) 

r_u = peak area from the Sample solution 

r_s = peak area from the Standard solution 

C = concentration of USP Dextrose RS in the Standard solution (g/100 mL) 

D = dilution factor for the Sample solution 

M_r1 = molecular weight of dextrose monohydrate, 198.17 

M_r2 = molecular weight of dextrose, 180.16 

Acceptance criteria: 4.5–5.5 g/100 mL of dextrose monohydrate (C₆H₁₂O₆ . H₂O) 

3.2 Dextran 70 

Sample solution: To 25 mL of Injection add 1 drop of 5 N ammonium hydroxide. 

Analysis: Determine the optical rotation (see Optical Rotation 〈781〉). 

Calculate the concentration, in g/100 mL, of dextran 70 in the volume of Injection taken: 

Result = (1/A_v1) × {[(F × a)/l] − [A_v2 × C_d × (M_r2/M_r1)]} 

A_v1 = average value for the specic rotation of dextran 70, 197.5 

F = conversion factor for 100 mL, 100 

a = observed optical rotation (°) 

l = length of the polarimeter tube (dm) 

A_v2 = average value for the specic rotation of dextrose, 52.75 

C_d = concentration of dextrose monohydrate as determined in the Assay for Dextrose (g/100 mL) 

M_r2 = molecular weight of dextrose, 180.16  

M_r1 = molecular weight of dextrose monohydrate, 198.17  

Acceptance criteria: 5.4–6.6 g/100 mL 

4 IMPURITIES 

4.1 Limit of 5-Hydroxymethylfurfural and Related Substances 

Sample solution: Dilute Injection with water to 2.0 mg/mL of dextrose monohydrate (C₆H₁₂O₆ . H₂O). 

6 12 6 2 

Instrumental conditions 

Analytical wavelength: 284 nm 

Cell: 1 cm 

Blank: Water 

Analysis 

Samples: Sample solution and Blank 

Acceptance criteria: Absorbance NMT 0.25 

5 SPECIFIC TESTS 

pH 〈791〉: 3.5–7.0 

Bacterial Endotoxins Test 〈85〉: NMT 0.5 USP Endotoxin Unit/mL 

Sterility Tests 〈71〉: Meets the requirements when tested as directed for Test for Sterility of the Product to Be Examined, Membrane Filtration • Color of Solution: Absorbance, determined at 375 nm against a water blank, is NMT 0.05. 

Other Requirements: It meets the requirements in Injections 〈1〉 and Particulate Matter in Injections 〈788〉. 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in single-dose glass or plastic containers. 

Labeling: The label states the total osmolar concentration in mOsmol/L. Where the contents are less than 100 mL, the label alternatively may state the total osmolar concentration in mOsmol/mL. 

USP Reference Standards 〈11〉