Dextran 40 in Dextrose Injection
» Dextran 40 in Dextrose Injection is a sterile solution of Dextran 40 and Dextrose in Water for Injection. It contains in each 100 mL not less than 9.0 g and not more than 11.0 g of Dextran 40 and not less than 4.1 g and not more than 5.0 g of dextrose (C6H12O6). It contains no bacteriostatic agents.
Packaging and storage
Preserve in single-dose glass or plastic containers.
Labeling
The label states the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, the label alternatively may state the total osmolar concentration in mOsmol per mL.
Color of solution
Its absorbance, determined at 375 nm against a water blank, is not greater than 0.06.
Identification
Dilute a portion quantitatively with dextrose solution (4.5 in 100) to a concentration of about 10 mg of Dextran 40 per mL. Using a capillary tube viscosimeter having dimensions such that the flow time of water is not less than 100 seconds, measure the flow times of the diluted Injection and that of a dextrose solution (4.5 in 100) at 20. Calculate the intrinsic viscosity by the formula:
{ln[(RD)(t / t0)]} / C
in which RD is the ratio of the density of the diluted Injection to that of the dextrose solution; t and t0 are the flow times for the diluted Injection and the dextrose solution, respectively; and C is the concentration, in g per mL, of Dextran 40 in the diluted Injection: the intrinsic viscosity is between 18 and 23 mL per g.
Bacterial endotoxins 85
It contains not more than 1.0 USP Endotoxin Unit per mL.
Sterility 71
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791:
between 3.0 and 7.0.
Heavy metals, Method II 231:
5 µg per mL.
Limit of 5-hydroxymethylfurfural and related substances
Dilute an accurately measured volume of Injection, equivalent to 1.0 g of C6H12O6·H2O, with water to 500.0 mL. Determine the absorbance of this solution in a 1-cm cell at 284 nm, using water as the blank: the absorbance is not more than 0.25.
Other requirements
It meets the requirements for Injections 1 and for Particulate Matter in Injections 788.
Assay for dextrose
Mobile phase
Use filtered and degassed 0.01 N sulfuric acid.
System suitability preparation
Prepare a solution in water containing 5 mg each of dextrose and xylitol per mL.
Standard preparation
Dissolve an accurately weighed quantity of USP Dextrose RS in water to obtain a solution having a known concentration of about 5 mg of dextrose monohydrate per mL.
Assay preparation
Transfer an accurately measured volume of Injection, equivalent to about 250 mg of dextrose monohydrate, to a 50-mL volumetric flask, dilute with water to volume, and mix.
Chromatographic system
(see Chromatography 621)The liquid chromatograph is equipped with a refractive index detector and a 7.8-mm × 30-cm column containing packing L17. The column and, if necessary, the detector are maintained at a constant temperature of about 40, and the flow rate is about 0.6 mL per minute. Chromatograph the System suitability preparation, and measure the peak responses as directed for Procedure: the resolution, R, between the dextrose and xylitol peaks is not less than 2.5. Chromatograph the Standard preparation as directed for Procedure: the relative standard deviation for replicate injections is not more than 1.5% for dextrose.
Procedure
Inject equal volumes (about 50 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the dextrose peaks. Calculate the concentration, in g per 100 mL, of dextrose monohydrate (C6H12O6·H2O) in the volume of Injection taken by the formula:
(198.17 / 180.16)C(rU / rS)
in which C is the concentration, in g per 100 mL, of USP Dextrose RS in the Standard preparation; and rU and rS are the peak areas obtained from the Assay preparation and the Standard preparation, respectively.
Assay for dextran 40
To 25 mL of Injection add 1 drop of 5 N ammonium hydroxide, and mix. Determine the optical rotation (see Optical Rotation 781), and calculate the concentration, in g per 100 mL, of Dextran 40 in the Injection taken by the formula:
(1 / 197.5)[(100a / l) (52.75Cd)]
in which 197.5 and 52.75 represent average values for the specific rotation of Dextran 40 and dextrose, respectively; a is the observed optical rotation in degrees; l is the length, in dm, of the polarimeter tube; and Cd is the concentration, in g per 100 mL, of dextrose as determined in the Assay for dextrose.
Auxiliary Information
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USP35NF30 Page 2855
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