Dextran 40 in Sodium Chloride 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 40 in Sodium Chloride Injection is a sterile solution of Dextran 40 and Sodium Chloride in Water for Injection. It contains in each 100 mL NLT 9.0 g and NMT 11.0 g of Dextran 40; and NLT 0.81 g and NMT 0.99 g of sodium chloride. It contains no bacteriostatic agents. 

2 IDENTIFICATION 

2.1 • A. 

Diluent: Sodium chloride solution (0.9 in 100) 

Sample solution: Injection, diluted with Diluent to 10 mg/mL of Dextran 40 

Analysis: Using a capillary tube viscometer with a ow time for water of 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 = Sample solution ow time 

t₀ = Diluent ow time 

C = concentration of Dextran 40 in the Sample solution (g/mL) 

Acceptance criteria: 18–23 mL/g 

3 ASSAY 

3.1 Sodium Chloride 

Sample solution: Pipet a volume of Injection, equivalent to 90 mg of chloride, into a porcelain casserole, and add 100 mL of water and 1 mL of dichlorouorescein TS. 

Analysis: Titrate with 0.1 N silver nitrate VS until the silver chloride occulates and the mixture acquires a faint pink color. Each mL of 0.1 N silver nitrate VS is equivalent to 5.844 mg of sodium chloride. 

Acceptance criteria: 0.81–0.99 g of sodium chloride per 100 mL 

3.2 Dextran 40 

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 per 100 mL, of Dextran 40 in the portion of Injection taken: 

Result = (a/l) × (1/A_v) × 100 

a = observed optical rotation (°) 

l = length of the polarimeter tube (dm) 

A_v = average value for the specic rotation of Dextran 40, 197.5 

Acceptance criteria: 9.0–11.0 g of Dextran 40 per 100 mL 

4 IMPURITIES 

5 SPECIFIC TESTS 

pH 〈791〉: 3.5–7.0 

Bacterial Endotoxins Test 〈85〉: It contains NMT 1.0 USP Endotoxin Unit/mL. 

Sterility Tests 〈71〉: It meets the requirements when tested as directed for Test for Sterility of the Product to Be Examined, Membrane Filtration.

Color of Solution: Its 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.