Dextran 70 in Dextrose Injection
» Dextran 70 in Dextrose Injection is a sterile solution of Dextran 70 and Dextrose in Water for Injection. It contains in each 100 mL not less than 5.4 g and not more than 6.6 g of dextran 70 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.
USP Reference standards 11—
USP Dextrose RS Click to View Structure
USP Endotoxin RS
Color of solution— Its absorbance, determined at 375 nm against a water blank, is not greater than 0.05.
Identification— Dilute a portion quantitatively with dextrose solution (4.5 in 100) to a concentration of about 10 mg of dextran 70 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 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 70 in the diluted Injection: the intrinsic viscosity is between 24 and 29 mL per g.
Bacterial endotoxins 85— It contains not more than 0.5 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 3.5 and 7.0.
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— Proceed as directed in the Assay for dextrose under Dextran 40 in Dextrose Injection except that the Assay preparation for Dextran 70 in Dextrose Injection is obtained by dilution with water (10 mL in 25 mL of water). Adjust the calculations of the dextrose content to take into consideration the dilution factor.
Assay for dextran 70— To 25 mL of Injection add 1 drop of 5 N ammonium hydroxide, and mix. Determine the optical rotation (see Optical Rotation 781) in a suitable polarimeter and calculate the concentration, in g per 100 mL, of dextran 70 in the Injection 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 70 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 of dextrose, in g per 100 mL, from the Assay for dextrose.
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Monograph Anita Y. Szajek, Ph.D.
Principal Scientific Liaison
1-301-816-8325		 (BIO12010) Monographs - Biologics and Biotechnology 1
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339		 (GCM2010) General Chapters - Microbiology
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339		 (GCM2010) General Chapters - Microbiology
USP35–NF30 Page 2857